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

Phase 2

Completed

• Conditions: Opioid-induced Constipation (OIC)
• Interventions: Drug: Placebo; Drug: TD-1211

• Registration Number: NCT01333540
• Lead Sponsor: Theravance Biopharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Study Start: 2011-05
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Disposition First Submitted: 2013-06-05
• Disposition First Submitted QC: 2013-06-05
• Disposition First Posted: 2013-06-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Active	TD-1211	Escalating Doses of TD-1211

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels	Continuous assessments for up to six weeks

Trial Locations

Locations (1)

Clinical Research Unit; 🇺🇸 Salt Lake City, Utah, United States