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

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid Induced Constipation

In brief

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

Key facts

Study ID

NCT01401985

Run by

Glycyx Therapeutics

People needed

95

Starts

2011-10-01

Expected to finish

2012-08-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Theravance Biopharma Investigational Site — Pasadena, California, United States

Full record on ClinicalTrials.gov

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