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

Theravance Biopharma

Status and phase: Completed; Phase 2

Conditions: Opioid Induced Constipation

Treatments: Drug: TD-1211; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459926

0084

Details and patient eligibility

About

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

Enrollment: 217 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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217 participants in 4 patient groups

Dose 1

Experimental group

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Dose 2

Experimental group

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Dose 3

Experimental group

Treatment:

Drug: TD-1211

Drug: TD-1211

Drug: TD-1211

Placebo

Experimental group

Treatment:

Drug: Placebo