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Trial · NCT01696643

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)CB-5945Had at least 1 TEAE58.5percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)PlaceboHad at least 1 TEAE54.0percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)CB-5945Had at least 1 drug-related TEAE19.9percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)PlaceboHad at least 1 drug-related TEAE12.1percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)CB-5945Discontinued treatment due to a TEAE10.0percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)PlaceboDiscontinued treatment due to a TEAE5.7percentage of participants
Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52CB-5945-12.456Standard Deviation 90.2190milligrams of METDD
Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52Placebo-12.297Standard Deviation 88.8681milligrams of METDD
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52CB-5945-0.63Standard Deviation 0.699units on a scale
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52Placebo-0.45Standard Deviation 0.583units on a scale
Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52CB-5945-3.0Standard Deviation 3.24units on a scale
Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52Placebo-2.2Standard Deviation 3.19units on a scale
Plasma Trough Concentrations of CB-5945CB-5945Week 4 (n=615)517.51Standard Deviation 403.391picograms per milliliter (pg/mL)
Plasma Trough Concentrations of CB-5945CB-5945Week 12 (n=522)549.66Standard Deviation 425.131picograms per milliliter (pg/mL)
Plasma Trough Concentrations of CB-5945CB-5945Week 24 (n=419)547.31Standard Deviation 453.548picograms per milliliter (pg/mL)
Plasma Trough Concentrations of CB-5945CB-5945Week 36 (n=288)573.57Standard Deviation 517.118picograms per milliliter (pg/mL)
Plasma Trough Concentrations of CB-5945CB-5945Week 52 (n=203)616.57Standard Deviation 725.849picograms per milliliter (pg/mL)
Plasma Trough Concentrations of CB-5945CB-5945Overall (n=631)517.19Standard Deviation 375.963picograms per milliliter (pg/mL)
Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal EventsCB-5945CV event1participants
Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal EventsPlaceboCV event2participants

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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