A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation

NCT01459926 | Completed Phase 2

• 1 other identifier: 0084
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation

Conditions

Opioid Induced Constipation

Keywords

Opioid induced constipation; OIC; Constipation; Opioid side effects; Morphine induced constipation; Opioid therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment

  Between weeks 2 and 5

Secondary Outcomes (1)

• Change from baseline in the weekly SBM frequency in the last week of treatment

  baseline and 5 weeks

Study Arms (4)

Dose 1

EXPERIMENTAL

Drug: TD-1211

Dose 2

EXPERIMENTAL

Drug: TD-1211

Dose 3

EXPERIMENTAL

Drug: TD-1211

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

TD-1211 DRUG

once daily

Dose 1

Placebo DRUG

Once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of constipation with onset after initiation of opioid therapy
• Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period
• Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the Screening Visit
• Willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation, treatment, and follow-up periods

You may not qualify if:

• Have participated in a clinical trial of an investigational drug or medical device within 30 days prior to Screening
• Have any condition that may affect drug absorption, (e.g., previous GI surgery)
• Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

G and L Research, LLC

Foley, Alabama, 36535, United States

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation

Interventions

3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

US (1)