Trial · NCT00830167
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC) | Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint | Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Sleep Quality Score at Endpoint | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness | Baseline, Week 15 or study discontinuation | The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used. | Scores 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/NCT00830167/outcomes