TriangleNCT01156142 · OUTCOME
Total Drowsiness Increase
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
- Up to 9 days
What was measured
The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis.
Analysis population: If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.
Groups in this outcome
Arm I (Doxepin-Placebo)
Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
Arm II (Placebo-Doxepin)
Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
| Group | Source count |
|---|---|
| Arm I (Doxepin-Placebo) | 69 |
| Arm II (Placebo-Doxepin) | 71 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Doxepin-Placebo) | -0.7 | 10.3 | Not reported | Not reported | Not reported |
| Arm II (Placebo-Doxepin) | -2.4 | 6.6 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0297
- param Type
- Mean Difference (Final Values)
- param Value
- 1.7
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- ci Lower Limit
- -1.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.6
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0297
- param Type
- Mean Difference (Final Values)
- param Value
- 1.7
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10.3
- value
- -0.7
- group Id
- OG001
- spread
- 6.6
- value
- -2.4
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 71
- units
- Participants
- description
- The total drowsiness increase will be calculated by the area under the curve (AUC) adjusting for baseline, with time scale replaced by a numerical scale of 1,2,3,4,5,6. The numerical scale will be used rather than the raw time scale in order to give proper weights to more immediate patient-reported mouth pain outcomes after treatment. The AUC will be calculated by proration when there are terminal missing data. If the missing data are intermittent, simple imputation will be applied to calculate the AUC. The question ('On a scale from 0 to 10, what number best describes your DROWSINESS now?') used 11-point numerical analog scales (0 (no drowsiness) to 10 (extreme drowsiness, leading to sleep) scores) to measure total drowsiness increase. The AUCs for the two treatment arms were compared by using the Wilcoxon rank sum test with 95% CIs. The statistical analysis will be the same as the primary analysis.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
- id
- OG000
- title
- Arm I (Doxepin-Placebo)
- description
- Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
- id
- OG001
- title
- Arm II (Placebo-Doxepin)
- param Type
- MEAN
- population Description
- If a patient cancels, is missing baseline data, or only provides baseline data, he/she will be excluded from the statistical analysis.
- reporting Status
- POSTED
- time Frame
- Up to 9 days
- title
- Total Drowsiness Increase
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice