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

NCT ID: NCT00977197

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pregabalin

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.

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

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.

Placebo

Subjects randomized to this arm will receive placebo matching the study drug.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

A matching placebo will be administered twice a day

Interventions

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.

Intervention Type: DRUG

Placebo

A matching placebo will be administered twice a day

Intervention Type: DRUG

Other Intervention Names

Lyrica

Eligibility Criteria

Inclusion Criteria

• Established diagnosis of Irritable Bowel Syndrome (IBS)
• Experience pain with relief with defecation
• 50/100 or greater of pain or discomfort scores during the two-week baseline period
• At least three pain attacks in a month, with at least three episodes of pain intensity equal to or exceeding 50/100
• U.S. resident
• English-speaking (able to provide consent and complete questionnaires)
• Able to participate in all aspects of the study

Exclusion Criteria

• Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, active celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, active pelvic floor dysfunction, paraplegia or quadriplegia);
• Current symptoms of severe depression, as measured by Hospital Anxiety and Depression Scale (HADS) score (greater or less than 15);
• Mental retardation or any condition requiring a legal guardian;
• Current or past history of psychotic disorder (schizophrenia, bipolar disorder)
• Recent or current use (within past 30 days) of drugs that interact with Pregabalin:
• Rosiglitazone (Avandia) or Pioglitazone (Actos)
• Narcotic anti-pain medications (e.g. oxycodone, morphine)
• Anti-anxiety medications (e.g. lorazepam, alprazolam, diazepam)
• Unable to withdraw medications at least 72 hours prior to the study, because we will evaluate patient's response to pregabalin therapy for relief of IBS-associated pain and disturbed sleep.

1. Non-narcotic anti-pain medications (e.g. nonsteroidal antiinflammatory drug (NSAIDs), ultram, neurontin, etc.)

2. Mexiletine, steroids, dextromethorphan.

3. Insomnia medications (e.g. benzodiazepines, zolpidem, diphenhydramine, melatonin, etc.)

• Planned surgery (especially transplant) or anesthesia exposure during trial
• Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, or abstinence)
• Recent or current use (within 30 days) of Pregabalin
• Known allergy to Pregabalin
• Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
• Recent history of alcohol or substance dependence use or abuse
• Another household member or relative participating in the study
• Professional drivers or operators of heavy machinery
• Major cardiovascular events in the last 6 months
• Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)
• Participation in another clinical trial (within 30 days)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Yuri A. Saito Loftus

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuri A Saito Loftus, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Mayo Clinic Health System - Franciscan Healthcare in La Crosse

La Crosse, Wisconsin, United States

Countries

United States

Other Identifiers

09-004404

Identifier Type: -

Identifier Source: org_study_id