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Completed

NCT Number: NCT01333540

A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients 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.

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Key information

Conditions

Opioid-induced Constipation (OIC) 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

Clinical Research Unit

Salt Lake City, Utah, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

TD-1211

Drug

Escalating doses

Placebo

Drug

Placebo once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels

    Time frame: Continuous assessments for up to six weeks

Sponsors and collaborators

Lead sponsor

Glycyx Therapeutics

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 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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