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

May 20, 2021 updated by: Theravance Biopharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Theravance Biopharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
Drug: TD-1211
Capsules
Experimental: Cohort 2
5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
Drug: TD-1211
Capsules
Experimental: Cohort 3
5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
Drug: TD-1211
Capsules
Experimental: Cohort 4
5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
Drug: TD-1211
Capsules
Experimental: Cohort 5
2 mg TD-1211 once daily for 14 days
Drug: Placebo
Capsules
Drug: TD-1211
Capsules
Experimental: Cohort 6
2.5 mg TD-1211 every 6 hours for 14 days
Drug: Placebo
Capsules
Drug: TD-1211
Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of TD-1211
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
Time Frame: Weekly assessments throughout Treatment Period
Change from baseline in the weekly SBM and CSBM frequency
Weekly assessments throughout Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD-1211-0076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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