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

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00391820
Enrollment
360
Registered
2006-10-24
Start date
2006-10-31
Completion date
2007-05-31
Last updated
2025-07-08

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

Conditions

Chronic Constipation

Keywords

constipation, chronic, bowel function

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.

Interventions

DRUGTD-5108

Sponsors

Theravance Biopharma
CollaboratorINDUSTRY
Alfasigma S.p.A.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
- Clinical response

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026