NCT00268879

Brief Summary

The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,821

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2005

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

December 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

2.1 years

First QC Date

December 22, 2005

Last Update Submit

February 13, 2008

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndromeConstipation-predominant irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of months a patient is a Responder for overall relief of IBS symptoms

    12 weeks

Secondary Outcomes (1)

  • Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention

    12 weeks

Study Arms (3)

1

PLACEBO COMPARATOR

Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Drug: Renzapride

2

EXPERIMENTAL

Renzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Drug: Renzapride

3

EXPERIMENTAL

Renzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.

Drug: Renzapride

Interventions

RenzaprideDRUG

Placebo Renzapride 4 mg QD Renzapride 2 mg BID

Also known as: ATL-1251, BRL-24924
123

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females with constipation predominant IBS as defined by the Rome II criteria
  • Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease

You may not qualify if:

  • Patients who have diarrhoea predominant or alternating symptom IBS
  • Other gastrointestinal diseases that affect bowel transit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alizyme

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

renzapride

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Anthony Lembo

    Beth Israel Deaconess Medical Centre, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

December 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

GB(1)