Trial · NCT01455428
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Mean Pain Score | Baseline | All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Mean Pain Score at Endpoint | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8 | Baseline and weekly from Weeks 1 to 8 | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline Mean Sleep Interference Score | Baseline | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Sleep Interference Score at Endpoint | Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8 | Baseline and weekly from Weeks 1 to 8 | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of 30 Percent (%) Responders at Endpoint | End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8 | Baseline; Weeks 1, 3, 5, and 8 | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point. | units on a scale | MEAN |
| SECONDARY | Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale | Baseline | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108 | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Pain VAS From the SF-MPQ at Endpoint | Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in PPI Scale From the SF-MPQ at Endpoint | Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores | Baseline | The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Had Optimal Sleep at Endpoint | Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint | Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint) | All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01455428/outcomes