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

Opioid-induced Constipation (OIC) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333540
• Other study ID #: 0074
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation (OIC)

Intervention

Drug:
• TD-1211
Escalating doses
• Placebo
Placebo once daily

Locations

Country	Name	City	State
United States	Clinical Research Unit	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels		Continuous assessments for up to six weeks