NCT00100425

Brief Summary

The purpose of this study is to provide new information and to determine which kinds of brief, tolerable, experimental pain are affected by the drugs being studied in patients with irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these studies to better understand what causes irritable bowel syndrome.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2004

Completed
Last Updated

January 21, 2009

Status Verified

December 1, 2004

First QC Date

December 30, 2004

Last Update Submit

January 20, 2009

Conditions

Keywords

Irritable Bowel SyndromeVisceral HypersensitivityVisceral Pain

Interventions

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with irritable bowel syndrome and healthy pain-free individuals (as controls) will be studied. * No medical condition that would contraindicate use of dextromethorphan, fentanyl or naloxone.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Malcolm Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeVisceral Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesNociceptive PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

December 30, 2004

First Posted

December 31, 2004

Study Start

September 1, 2000

Last Updated

January 21, 2009

Record last verified: 2004-12

Locations