NCT00516503 · OUTCOME
Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer · Source last updated 2017-08-24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- At 4 weeks
What was measured
Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.
Groups in this outcome
Baclofen-amitriptyline Hydrochloride-ketamine
Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
Placebo
Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 101 |
|---|
| Placebo | 102 |
|---|
Reported measurements
POMS Tension-Anxiety Subscale
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 83.2 | 17.09 | Not reported | Not reported | Not reported |
|---|
| Placebo | 83.0 | 15.73 | Not reported | Not reported | Not reported |
|---|
POMS VA Subscale
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 31.1 | 18.42 | Not reported | Not reported | Not reported |
|---|
| Placebo | 33.0 | 19.61 | Not reported | Not reported | Not reported |
|---|
POMS Anger-Hostility Score
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 87.8 | 14.48 | Not reported | Not reported | Not reported |
|---|
| Placebo | 87.7 | 12.98 | Not reported | Not reported | Not reported |
|---|
POMS Confusion-Bewilderment
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 76.9 | 17.58 | Not reported | Not reported | Not reported |
|---|
| Placebo | 77.9 | 11.75 | Not reported | Not reported | Not reported |
|---|
POMS Depression-Dejection Score
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 86.4 | 16.09 | Not reported | Not reported | Not reported |
|---|
| Placebo | 85.8 | 15.23 | Not reported | Not reported | Not reported |
|---|
POMS Fatigue-Inertia Score
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 67.2 | 21.69 | Not reported | Not reported | Not reported |
|---|
| Placebo | 63.6 | 22.22 | Not reported | Not reported | Not reported |
|---|
Mean POMS Score
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baclofen-amitriptyline Hydrochloride-ketamine | 71.5 | 13.27 | Not reported | Not reported | Not reported |
|---|
| Placebo | 71.8 | 13.14 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.09
- value
- 83.2
- group Id
- OG001
- spread
- 15.73
- value
- 83.0
- title
- POMS Tension-Anxiety Subscale
- categories
- measurements
- group Id
- OG000
- spread
- 18.42
- value
- 31.1
- group Id
- OG001
- spread
- 19.61
- value
- 33.0
- title
- POMS VA Subscale
- categories
- measurements
- group Id
- OG000
- spread
- 14.48
- value
- 87.8
- group Id
- OG001
- spread
- 12.98
- value
- 87.7
- title
- POMS Anger-Hostility Score
- categories
- measurements
- group Id
- OG000
- spread
- 17.58
- value
- 76.9
- group Id
- OG001
- spread
- 11.75
- value
- 77.9
- title
- POMS Confusion-Bewilderment
- categories
- measurements
- group Id
- OG000
- spread
- 16.09
- value
- 86.4
- group Id
- OG001
- spread
- 15.23
- value
- 85.8
- title
- POMS Depression-Dejection Score
- categories
- measurements
- group Id
- OG000
- spread
- 21.69
- value
- 67.2
- group Id
- OG001
- spread
- 22.22
- value
- 63.6
- title
- POMS Fatigue-Inertia Score
- categories
- measurements
- group Id
- OG000
- spread
- 13.27
- value
- 71.5
- group Id
- OG001
- spread
- 13.14
- value
- 71.8
- title
- Mean POMS Score
- denoms
- counts
- group Id
- OG000
- value
- 101
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- Each mood scale (0 - 100, higher is better mood) will be analyzed as an endpoint along with the total mood disturbance score.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Baclofen/amitriptyline/ketamine gel: Applied topically.
- id
- OG000
- title
- Baclofen-amitriptyline Hydrochloride-ketamine
- description
- Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks. Placebo: Applied topically
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- At 4 weeks
- title
- Mood States and Total Mood Disturbance as Measured by the Profile of Mood States (POMS)
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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