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A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome

NCT00977197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2016-10-28

Study results available
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Summary

This study is being done to see if Lyrica helps people with irritable bowel syndrome.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Pregabalin

Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.

DRUG

Placebo

A matching placebo will be administered twice a day

Sponsors & Collaborators

Principal Investigators

  • Yuri A Saito Loftus, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977197 on ClinicalTrials.gov