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, Inc.
ClinicalTrials.gov Identifier:
NCT01333540
First received: March 30, 2011
Last updated: June 5, 2013
Last verified: June 2013

March 30, 2011
June 5, 2013
May 2011
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01333540 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Safety, Tolerability and Clinical Activity of TD−1211 in Patients With Opioid-Induced Constipation
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Opioid-induced Constipation (OIC)
  • Drug: TD-1211
    Escalating doses
  • Drug: Placebo
    Placebo once daily
  • Experimental: Active
    Escalating Doses of TD-1211
    Intervention: Drug: TD-1211
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01333540
0074
No
Theravance, Inc.
Theravance, Inc.
Not Provided
Not Provided
Theravance, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP