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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01333540
First received: March 30, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Opioid-induced Constipation (OIC)
Drug: TD-1211
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211 [ Time Frame: Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels [ Time Frame: Continuous assessments for up to six weeks ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Escalating Doses of TD-1211
Drug: TD-1211
Escalating doses
Placebo Comparator: Placebo Drug: Placebo
Placebo once daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333540

Locations
United States, Utah
Clinical Research Unit
Salt Lake City, Utah, United States
Sponsors and Collaborators
Theravance Biopharma Antibiotics, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier: NCT01333540     History of Changes
Other Study ID Numbers: 0074
Study First Received: March 30, 2011
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
constipation
opioid induced

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014