NCT00538850 · REGISTRY CONDITION SEARCH

Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2014-03-05

This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

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outcome · POSTED

Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)

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outcome · POSTED

Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing

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outcome · POSTED

Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing

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outcome · POSTED

Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Male or female, ≥ 18 years of age. * Diagnosis of cancer. * Opioid-tolerant. Subjects who were opioid tolerant were those taking ≥ 60 mg of oral morphine/day, at least 25 μg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer for cancer-related pain. * Experienced persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit. * Over the previous 7 days, subject experienced, on average, 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen). * Able to evaluate and record pain relief, assess medication performance at set times after dosing, record AEs, record each use of the study drug or supplemental medication in an electronic diary (a caregiver may have provided the subject the medication, help with the mechanics of handling the electronic diary but was not permitted to record any information in the electronic diary). * Able and willing to give informed consent. * Women of childbearing potential were to have a) a negative serum pregnancy test, b) not be breastfeeding and c) agree to practice a reliable form of contraception. Exclusion Criteria: * Intolerance to opioids or fentanyl. * Current use of commercially available oral short-acting fentanyl for breakthrough pain. Subjects previously on Actiq or Fentora were permitted to be enrolled if they had a 7 day washout. * Rapidly increasing/uncontrolled pain. * A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids. * Uncontrolled hypertension (systolic blood pressure {SBP} \> 180 mmHg or diastolic blood pressure \[DBP\] \> 90 mmHg on 2 occasions ≥ 6 hours apart) despite antihypertensive therapy, or a history of hypertensive crisis within the past 2 years. * A recent history (≤ 2 years prior) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms. * Clinically uncontrolled sleep apnea. * Brain metastases with signs or symptoms of increased intracranial pressure. * Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy. * Received investigational study product(s) ≤ 30 days prior to the Screening Visit. * Painful erythema, oedema or ulcers under the tongue. * Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
intervention Names
Drug: Fentanyl sublingual spray
Drug: Placebo
label
Fentanyl sublingual spray
type
EXPERIMENTAL

interventions

arm Group Labels
Fentanyl sublingual spray
description
In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. In the double-blind period of the study, participants received fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, or 1600 µg determined in the open-label titration period of the study.
name
Fentanyl sublingual spray
other Names
SUBSYS
type
DRUG
arm Group Labels
Fentanyl sublingual spray
description
Matching placebo to fentanyl sublingual spray.
name
Placebo
type
DRUG

Study design

intervention Model

CROSSOVER

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 130
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.
measure
Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)
time Frame
Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode

secondary Outcomes

description
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5\*PID5), SPID10=(5\*PID5)+(5\*PID10), SPID15=(5\*PID5)+(5\*PID10)+(5\*PID15), SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30), SPID45=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30)+(15\*PID45), SPID60=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30) +(15\*PID45) +(15\*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.
measure
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
time Frame
Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode
description
Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5\*PAR5), TOTPAR10=(5\*PAR5)+(5\*PAR10), TOTPAR15=(5\*PAR5)+(5\*PAR10)+(5\*PAR15), TOTPAR30=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30), TOTPAR45=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30)+(15\*PAR45), TOTPAR60=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30) +(15\*PAR45) +(15\*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.
measure
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
time Frame
5 through 60 minutes after dosing for each pain episode
description
Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.
measure
Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
time Frame
30 through 60 minutes after dosing for each pain episode

Full study description

brief Summary: This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods).
detailed Description: RATIONALE Fentanyl sublingual spray may help relieve breakthrough pain in patients receiving opioids for cancer pain. OBJECTIVES Primary * Determine the efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in patients on around-the-clock opioids for their persistent cancer pain. Secondary * Evaluate the safety of fentanyl sublingual spray in these opioid-tolerant patients. * Assess the patient's satisfaction with treatment medication.

Source references

references

citation
Rauck R, Reynolds L, Geach J, Bull J, Stearns L, Scherlis M, Parikh N, Dillaha L. Efficacy and safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin. 2012 May;28(5):859-70. doi: 10.1185/03007995.2012.683111. Epub 2012 May 2.
pmid
22480131
type
RESULT
citation
Alberts DS, Smith CC, Parikh N, Rauck RL. Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl. Pain Manag. 2016 Oct;6(5):427-34. doi: 10.2217/pmt-2015-0009. Epub 2016 Mar 29.
pmid
27020837
type
DERIVED

Source notices and limitations

Discovery and provenance

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Source null
source file sha256
9c84fe83f9fcdb12f3a6bb624863442db2afcee53df61c38a03e4f013f7f76a1
payload sha256
bfd4a3c97982dcac2010d7947142a68751d5d5ad4cf30eb041e336ce700c2e1b
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-4d123ed589830e7d285f
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00538850
occurrences
context exact
NCT00538850
end
11
exact text
NCT00538850
start
0
offset unit
unicode_code_points
query cond
Vulvar Cancer
query disease state id
ds-vulvar-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vulvar-cancer-000.json
source file sha256
9c84fe83f9fcdb12f3a6bb624863442db2afcee53df61c38a03e4f013f7f76a1
source json pointer
/studies/1/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
5d0d77dee6d87f2f2ad4711a9ec8057b9d0bc64a378a6e8379a87422316179eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vulvar+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-5dfaf893ffb6a3842e54
requested nct id
NCT00538850
primary nct id
NCT00538850
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Malignant+Mesothelioma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
payload sha256
6cbaf8ea7edd0df105ef1ef2499571e2506267bde1dcaa50750c2247ba3e6618
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-5dfaf893ffb6a3842e54
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00538850
occurrences
context exact
NCT00538850
end
11
exact text
NCT00538850
start
0
offset unit
unicode_code_points
query cond
Malignant Mesothelioma
query disease state id
ds-malignant-mesothelioma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-malignant-mesothelioma-000.json
source file sha256
0a018dbf1aa46f57978b6d16aa19b94d76d6d65cf1e297e889c8e599fef1fab1
source json pointer
/studies/0/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
5d0d77dee6d87f2f2ad4711a9ec8057b9d0bc64a378a6e8379a87422316179eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Malignant+Mesothelioma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-5dfe7bc1ad0f091303ce
requested nct id
NCT00538850
primary nct id
NCT00538850
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Testicular+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
payload sha256
8aed037e878f191fec36c44b5de677ad93155f193c009d0ad7953dc8ca582fca
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-5dfe7bc1ad0f091303ce
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00538850
occurrences
context exact
NCT00538850
end
11
exact text
NCT00538850
start
0
offset unit
unicode_code_points
query cond
Testicular Cancer
query disease state id
ds-testicular-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
source file sha256
9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
source json pointer
/studies/2/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
5d0d77dee6d87f2f2ad4711a9ec8057b9d0bc64a378a6e8379a87422316179eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Testicular+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-69178ffbb4501c2869f7
requested nct id
NCT00538850
primary nct id
NCT00538850
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Penile+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
e9517ade36d469a7fd2e8b9c24ac926bac342fd6e763013a79e66e2d510f9bb7
payload sha256
44d2244c15ecb1baa77705fe5d7ca3e819a1ba0deddc1eb25f7acb07962a357f
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-69178ffbb4501c2869f7
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00538850
occurrences
context exact
NCT00538850
end
11
exact text
NCT00538850
start
0
offset unit
unicode_code_points
query cond
Penile Cancer
query disease state id
ds-penile-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-penile-cancer-000.json
source file sha256
e9517ade36d469a7fd2e8b9c24ac926bac342fd6e763013a79e66e2d510f9bb7
source json pointer
/studies/0/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
5d0d77dee6d87f2f2ad4711a9ec8057b9d0bc64a378a6e8379a87422316179eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Penile+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-6ca46fbfc010fb91be54
requested nct id
NCT00538850
primary nct id
NCT00538850
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
payload sha256
cc4a8e9d616513b638ac1825172a63f2095c7c7e10c667a334bd7600e2a63b5d
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-6ca46fbfc010fb91be54
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00538850
occurrences
context exact
NCT00538850
end
11
exact text
NCT00538850
start
0
offset unit
unicode_code_points
query cond
Juvenile Myelomonocytic Leukemia
query disease state id
ds-juvenile-myelomonocytic-leukemia
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
source json pointer
/studies/4/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
5d0d77dee6d87f2f2ad4711a9ec8057b9d0bc64a378a6e8379a87422316179eb
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice