Trial · NCT00830128
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 53 weeks | All participants who received at least 1 dose of the study medication. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who have taken at least 1 dose of the study medication, regardless of compliance with the study medication, and have at least 1 postbaseline efficacy assessment. | mm | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Snoring at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Awaken Short of Breath or With a Headache at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Adequacy at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Quantity of Sleep at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | hours | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Somnolence at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Overall Sleep Problems Index at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Medical Outcomes Study (MOS) Sleep Scale - Optimal Sleep at Endpoint | Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Paticipants | NUMBER |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Total Scores at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) - Subscale Score at Endpoint | Baseline, Week 52 or Study Discontinuation | All participants who received at least 1 dose of the study medication, regardless of compliance with the study medication, and had at least 1 postbaseline efficacy assessment. | Units on a scale | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00830128/outcomes