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Trial · NCT01965652

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Adverse EventsFrom the first dose of study drug up to 14 days after the last dose of study drug (54 weeks).Safety populationparticipantsNUMBER
SECONDARYChange From Baseline in the Number of Bowel Movements Per WeekBaseline and Weeks 12, 24, 36, and 52The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.bowel movements / weekLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants Meeting Each Criterion of Laxative UseFrom 28 days prior to screening until the end of the treatment period (total of 56 weeks)Intent-to-treat populationpercentage of participantsNUMBER
SECONDARYChange From Baseline in the Overall Score for Patient Assessment of Constipation SymptomsBaseline and Weeks 2, 12, 24, 36, and 52The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the PAC-SYM Abdominal-symptoms Domain ScoreBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the PAC-SYM Rectal-symptoms Domain ScoreBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the PAC-SYM Stool-symptoms Domain ScoreBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Patient Assessment of Constipation Quality of Life Overall ScoreBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treatunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Physical Discomfort Domain of PAC-QOLBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Psychosocial Discomfort Domain of PAC-QOLBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Worries and Concerns Domain of PAC-QOLBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Satisfaction Domain of PAC-QOLBaseline and Weeks 2, 12, 24, 36, and 52Intent-to-treat populationunits on a scaleLEAST_SQUARES_MEAN
SECONDARYParticipant Global SatisfactionWeek 52 or early termination visitIntent-to-treat populationpercentage 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.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT01965652/outcomes