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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01459926

Enrollment

217

Registered

2011-10-26

Start date

2011-11-01

Completion date

2012-06-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Induced Constipation

Keywords

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

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

Interventions

DRUGTD-1211

once daily

DRUGPlacebo

Once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment	Between weeks 2 and 5

Secondary

Measure	Time frame
Change from baseline in the weekly SBM frequency in the last week of treatment	baseline and 5 weeks

Countries

United States

Contacts

STUDY_DIRECTORMedical Monitor

Theravance Biopharma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026