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Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)

Primary Purpose

Chronic Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TD-5108
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring constipation, chronic, bowel function

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet ROME III Criteria

Exclusion Criteria:

  • Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function
  • Chronic treatment with anticholinergics, narcotic analgesics
  • Irritable Bowel Syndrome

Sites / Locations

  • Breco Research

Outcomes

Primary Outcome Measures

- Clinical response

Secondary Outcome Measures

Full Information

First Posted
October 20, 2006
Last Updated
December 1, 2014
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT00391820
Brief Title
Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
constipation, chronic, bowel function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TD-5108
Primary Outcome Measure Information:
Title
- Clinical response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet ROME III Criteria Exclusion Criteria: Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function Chronic treatment with anticholinergics, narcotic analgesics Irritable Bowel Syndrome
Facility Information:
Facility Name
Breco Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21039672
Citation
Goldberg M, Li YP, Johanson JF, Mangel AW, Kitt M, Beattie DT, Kersey K, Daniels O. Clinical trial: the efficacy and tolerability of velusetrag, a selective 5-HT4 agonist with high intrinsic activity, in chronic idiopathic constipation - a 4-week, randomized, double-blind, placebo-controlled, dose-response study. Aliment Pharmacol Ther. 2010 Nov;32(9):1102-12. doi: 10.1111/j.1365-2036.2010.04456.x. Epub 2010 Sep 22.
Results Reference
derived

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Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)

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