Irritable Bowel Syndrome | A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Irritable Bowel Syndrome research study
What is the primary objective of this study?
This study is being done to see if Lyrica helps people with irritable bowel syndrome.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Irritable Bowel Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PregabalinDose: 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:PlaceboA matching placebo will be administered twice a day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PregabalinSubjects 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.
PlaceboSubjects randomized to this arm will receive placebo matching the study drug.
Start Date: March 2010
Completed Date: June 2015
Phase: Phase 2
Primary Outcome: Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
Secondary Outcome: Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
Study sponsors, principal investigator, and references
Principal Investigator: Yuri A Saito Loftus, MD
Lead Sponsor: Mayo Clinic