A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Pregabalin; Placebo
Intervention description: 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.; A matching placebo will be administered twice a day
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

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

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)