Trial · NCT00333866
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | Baseline, Week 14 | Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Patient Global Impression of Change (PGIC) | Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Mean Sleep Quality Score | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group, respectively. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 | Baseline, Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Total Daily Acetaminophen Dose | Week 14 | FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | mg/day | 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.
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