A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation

May 19, 2026 updated by: Glycyx Therapeutics
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • G and L Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • History of constipation with onset after initiation of opioid therapy
  • Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period
  • Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the Screening Visit
  • Willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation, treatment, and follow-up periods

Exclusion Criteria:

  • Have participated in a clinical trial of an investigational drug or medical device within 30 days prior to Screening
  • Have any condition that may affect drug absorption, (e.g., previous GI surgery)
  • Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
Once daily
Experimental: Dose 1
Drug: TD-1211
once daily
Drug: TD-1211
Once daily
Experimental: Dose 2
Drug: TD-1211
once daily
Drug: TD-1211
Once daily
Experimental: Dose 3
Drug: TD-1211
once daily
Drug: TD-1211
Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
Time Frame: Between weeks 2 and 5
Between weeks 2 and 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the weekly SBM frequency in the last week of treatment
Time Frame: baseline and 5 weeks
baseline and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glycyx Therapeutics

Collaborators

Theravance Biopharma

Investigators

  • Study Director: Medical Monitor, Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimated)

October 26, 2011

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0084

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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