NCT00552565

Brief Summary

The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) in the treatment of IBS-D.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
711

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

1.8 years

First QC Date

October 31, 2007

Last Update Submit

June 10, 2009

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

IBS, IBS-D, R-verapamil, Arverpamil, Rezular

Outcome Measures

Primary Outcomes (1)

  • Adequate Relief

    8 weeks

Study Arms (4)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: Rezular 15mg

Rezular 37.5mg

EXPERIMENTAL
Drug: Rezular

Rezular - 75mg

EXPERIMENTAL
Drug: Rezular

Interventions

Rezular 15mgDRUG

Oral Tablets

2
PlaceboDRUG

placebo

1
RezularDRUG

Rezular 37.5mg 3xday up to 12 weeks

Rezular 37.5mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fulfilling Rome III criteria for IBS-D

You may not qualify if:

  • major cardiovascular disease
  • psychiatric illness except mild or moderate depression
  • pregnancy
  • presence of other GI disease that could explain IBS-like symptoms
  • history of major gastric, hepatic, pancreatic or intestinal surgery or perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Ichthyosis Bullosa of Siemens

Condition Hierarchy (Ancestors)

IchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

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
OTHER

Study Record Dates

First Submitted

October 31, 2007

First Posted

November 2, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

US(1)