Conditions: Irritable Bowel Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

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

Detailed description:
Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including irritable bowel syndrome-related conditions such as fibromyalgia.

Arms:
arm 1: Subjects randomized to this arm will receive the following dosage:

75 mg (one tablet) 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. arm 2: Subjects randomized to this arm will receive placebo matching the study drug.

Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: A matching placebo will be administered twice a day

Protocol document: