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Trial · NCT01701362

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYBaseline Mean Pain ScoreBaselineIntent to Treat (ITT) population: all randomized participants who took at least one dose of study drugunits on a scaleMEAN
PRIMARYChange From Baseline to Week 15 in Weekly Mean Pain Scoreup to Week 15ITT population: all randomized participants who took at least one dose of study drugunits on a scaleLEAST_SQUARES_MEAN
SECONDARYPatient Global Impression of Change (PGIC) at Week 15Week 15ITT population: all randomized participants who took at least one dose of study drugParticipantsNUMBER
SECONDARYChange From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)up to Week 15ITT population: all randomized participants who took at least one dose of study drugunits on a scaleMEAN
SECONDARYChange From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])Week 15ITT population: all randomized participants who took at least one dose of study drugunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Pain Interference Index (BPI-sf)Week 15ITT population: all randomized participants who took at least one dose of study drugunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile ScoresWeek 15ITT population: all randomized participants who took at least one dose of study drugUnits on a scaleLEAST_SQUARES_MEAN
SECONDARYBaseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.BaselineITT population: all randomized participants who took at least one dose of study drug.Units on a scaleMEDIAN
SECONDARYMean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.Week 15ITT population: all randomized participants who took at least one dose of study drug.Units on a scaleLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants in MOS-SS With Optimal Sleep Status.Week 15ITT population: all randomized subjects who took at least one dose of study drugPercentage of participantsNUMBER
SECONDARYPercentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.Week 15ITT population: all randomized participants who took at least one dose of study drugPercentage of participantsNUMBER
SECONDARYPercentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%Week 15ITT population: all randomized participants who took at least one dose of study drugPercentage of participantsNUMBER

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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