A Study to Assess the Safety, Tolerability and Clinical A... | NCT01333540

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

NCT01333540

Sponsor

Glycyx Therapeutics

Status

Completed

Last Update Posted

May 22, 2026Actual

Enrollment

69Actual

Phase

Phase 2

Conditions

Opioid-induced Constipation (OIC)

Interventions

TD-1211
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

May 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 30, 2011

First Submission Date that Met QC Criteria

Apr 11, 2011

First Posted Date

Apr 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 5, 2013

Certification/Extension First Submitted that Passed QC Review

Jun 5, 2013

Certification/Extension First Posted Date

Jun 13, 2013Estimated

Last Update Submitted Date

May 19, 2026

Last Update Posted Date

May 22, 2026Actual

Name	Class
Theravance Biopharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Escalating Doses of TD-1211	Drug: TD-1211
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TD-1211	Drug	Escalating doses	Active
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211		Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels		Continuous assessments for up to six weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Theravance Biopharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Unit		Salt Lake City	Utah		United States

Condition Browse Module

MeSH Terms

ID	Term
D000079689	Opioid-Induced Constipation
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D000079524	Narcotic-Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C585268	3-(8-(2-(cyclohexylmethyl(2,3-dihydroxypropionyl)amino)ethyl)-8-azabicyclo(3.2.1)oct-3-yl)benzamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided