A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

May 19, 2026 updated by: Glycyx Therapeutics

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Clinical Activity of TD-1211 in Subjects With Opioid-Induced Constipation

A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

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
    • Utah
      • Salt Lake City, Utah, United States
        • Clinical Research Unit

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:

  • Males and females between 18 and 65 years of age, inclusive
  • Subjects with documented OIC on stable opioid regimen
  • Willingness to stop all laxatives throughout run-in and treatment period

Exclusion Criteria:

  • Any clinically significant findings in subjects with OIC
  • Have participated in another clinical trial of an investigational drug 30 days prior to screening
  • History of chronic constipation prior to opioid therapy in OIC subjects
  • Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo once daily
Experimental: Active
Escalating Doses of TD-1211
Drug: TD-1211
Escalating doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211
Time Frame: Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks
Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels
Time Frame: Continuous assessments for up to six weeks
Continuous assessments for up to six 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

May 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

April 11, 2011

First Posted (Estimated)

April 12, 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

  • 0074

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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