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Trial · NCT02656017

Outcomes14

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in the Gastrointestinal Symptoms Rating Scale (GSRS) to 24 MonthsBaseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 monthsscore on a scaleMEAN
PRIMARYDrug TolerabilityBaseline, 2 weeks, 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYRate of Serious Adverse Events (SAE)26 monthsParticipants who received and took metformin or placeboParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYQuality of Life Physical ComponentBaseline, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisscore on a scaleMEAN
SECONDARYQuality of Life Mental ComponentBaseline, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisscore on a scaleMEAN
SECONDARYBack Pain Frequency Over the Past 3 Months Since Last VisitBaseline, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisodds ratioNUMBER
SECONDARYEstimated Glomerular Filtration Rate (eGFR)Baseline, 2 weeks, and 6 weeks, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisml/min/1.73m^2MEAN
SECONDARYTotal Kidney Volume From Magnetic Resonance ImagingBaseline, 6 months, 12 months, 18 months, 24 monthsIntention to treat analysisannual percent changeMEAN
SECONDARYTotal Kidney Cyst Volume From Magnetic Resonance ImagingBaseline, 6 months, 12 months, 18 months, 24 monthsIntention to treat analysisannual percent changeMEAN
SECONDARYLiver Volume From Magnetic Resonance ImagingBaseline, 6 months, 12 months, 18 months, 24 monthsIntention to treat analysisannual percent changeMEAN
SECONDARYLiver Cyst Volume From Magnetic Resonance ImagingBaseline, 6 months, 12 months, 18 months, 24 monthsIntention to treat analysisannual percent changeMEAN
SECONDARYFrequency Abdominal Fullness Interfered With Ability to Perform Usual Physical Activity Over the Past 3 Months Since Last Visit.Baseline, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisodds ratioNUMBER
SECONDARYInterference of Pain With Sleep Over the Past 3 Months Since Last VisitBaseline, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisodds ratioNUMBER
SECONDARYInterference of Pain With Strenuous Physical Activity Over the Past 3 Months Since Last VisitBaseline, 1 month, 3 months and every 3 months thereafter to 24 monthsIntention to treat analysisodds ratioNUMBER

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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