Trial · NCT02187159
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 | Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | ADPS was assessed using the modified intent-to-treat (mITT) analysis set. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Answered Much Improved or Better on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo | Week 13 postdose | PGIC was assessed using the modified intent-to-treat (mITT) analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | FIQ was assessed using the modified intent-to-treat (mITT) analysis set. | units on a scale | MEAN |
| SECONDARY | Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo | Week 13 postdose | Responder rates were assessed using the modified intent-to-treat (mITT) analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | Multidimensional Fatigue Inventory (MFI-20) was assessed in the modified intent-to-treat (mITT) population. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | HADS was assessed using the modified intent-to-treat (mITT) analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | This outcome was assessed using the modified intent-to-treat analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | The EQ-5D was assessed using the modified intent-to-treat (mITT) analysis set. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | Pain-associated sleep interference was assessed using the modified intent-to-treat (mITT) analysis set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo | Week 13 postdose | The MOS sleep scale outcome was assessed in the modified intent-to-treat (mITT) analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo | Baseline up to Week 13 postdose | BFI-SF was assessed using the modified intent-to-treat (mITT) analysis set. | units on a scale | MEAN |
| SECONDARY | Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo | Week 1 to Week 13 postdose | Rescue medication usage was assessed using the modified intent-to-treat (mITT) analysis set. | proportion of days | 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/NCT02187159/outcomes