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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00977197

09-004404

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups, including a placebo group

Pregabalin

Active Comparator group

Description:

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.

Treatment:

Drug: Pregabalin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo