This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments pregabalin (lyrica), placebo
Phase phase 2
Sponsor Mayo Clinic
Collaborator Pfizer
Start date March 2010
End date June 2015
Trial size 97 participants
Trial identifier NCT00977197, 09-004404


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Pregabalin (Lyrica) is an FDA-approved prescription medication that was initially developed at Northwestern University and was approved in the European Union in 2004. It has been shown in several clinical trials to effectively treat patients with epilepsy, diabetic neuropathy pain, and post-herpetic neuralgia pain. It is relatively inexpensive compared to other irritable bowel syndrome-diarrhea predominant medications and has a low side-effect profile. To date, no study has been performed in the United States examining the clinical effects of Pregabalin in IBS patients.
pregabalin (lyrica) Lyrica
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 Comparator)
Placebo, not active
placebo Lyrica
A matching placebo will be administered twice a day

Primary Outcomes

Primary aim: Collect preliminary data comparing effects of Pregabalin and placebo on abdominal pain/discomfort on bowel symptom score (BSS), overall BSS score, and adequate relief of irritable bowel syndrome (IBS) symptoms in patients with IBS
time frame: weekly

Secondary Outcomes

To compare the effect of Pregabalin and placebo on self-reported overall and individual BSS scores
time frame: Last 4 weeks of treatment
compare effect of Pregabalin and placebo on adequate relief of IBS pain or discomfort at least 50% of the time
time frame: During the last 4 weeks of therapy
To compare effect of Pregabalin and placebo on overall and individual BSS scores
time frame: Week 12
To compare the effect of Pregabalin and placebo on the proportion of patients with at least 3 point changes in 11 point pain and IBS scores
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Established diagnosis of 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 - 18-70 years of age - 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)

Additional Information

Official title A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.