NCT00391820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

July 8, 2025

Status Verified

December 1, 2014

First QC Date

October 20, 2006

Last Update Submit

July 3, 2025

Conditions

Chronic Constipation

Keywords

constipationchronicbowel function

Outcome Measures

Primary Outcomes (1)

  • - Clinical response

Interventions

TD-5108DRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet ROME III Criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breco Research

Houston, Texas, 77024, United States

Location

Related Publications (1)

  • 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.

    PMID: 21039672DERIVED

MeSH Terms

Conditions

ConstipationBronchiolitis Obliterans Syndrome

Interventions

TD-5108

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

October 1, 2006

Study Completion

May 1, 2007

Last Updated

July 8, 2025

Record last verified: 2014-12

Locations

US(1)