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Completed

NCT Number: NCT01401985

A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation

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Key information

Conditions

Opioid Induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Theravance Biopharma Investigational Site

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stable dose of opioids for at least 12 weeks before screening visit
  • less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation
  • willing to stop laxatives and other bowel treatments; rescue laxative allowed

Exclusion criteria

  • Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)
  • Have participated in another clinical trial of an investigational drug 30 days prior to screening
  • History of cancer treatment except adequately treated localized skin cancer within 5 years of screening
  • History of chronic constipation prior to opioid therapy
  • Females who are pregnant or breast feeding
  • Have any condition that may affect drug absorption (e.g. previous GI surgery)

Treatment and study plan

TD-1211

Drug

Capsules

Placebo

Drug

Capsules

Primary outcomes

  1. Safety and tolerability of TD-1211

    Time frame: 14 days

Secondary outcomes

  1. Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)

    Time frame: Weekly assessments throughout Treatment Period

    Change from baseline in the weekly SBM and CSBM frequency

Sponsors and collaborators

Lead sponsor

Glycyx Therapeutics

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study title

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2011
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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