Trial · NCT01432236
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean NRS Pain Score at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | MEAN |
| SECONDARY | FIQ Score at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Change (PGIC) at the End of Period 1. | End of Period 1 at Week 6 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | PGIC at the End of Period 2. | End of Period 2 at Week 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary. | Visits 2, 6, and 12 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Percentage of participants | NUMBER |
| SECONDARY | Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Number of times awakened | LEAST_SQUARES_MEAN |
| SECONDARY | Hospital Anxiety and Depression Scale (HADS) at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | MEAN |
| SECONDARY | HADS at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | MEAN |
| SECONDARY | EQ-5D Score at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Mean Patient Static Global Assessment (PSGA) Score at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Mean PSGA Score at End of Period. | End of each period, at Weeks 6 and 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. | From Visit 3 to Visit 14 | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline. | Baseline | ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. | 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.
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