Trial · NCT01387607
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14 | Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Sleep Interference Score at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO) | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO) | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO) | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST) | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14 | Baseline, Week 14 | The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used. | 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/NCT01387607/outcomes