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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier:
First received: September 11, 2009
Last updated: September 29, 2015
Last verified: September 2015
This study is being done to see if Lyrica helps people with irritable bowel syndrome.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Pregabalin (Lyrica)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effect of Pregabalin and placebo on self-reported overall and individual BSS scores [ Time Frame: Last 4 weeks of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare effect of Pregabalin and placebo on overall and individual BSS scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: March 2010
Estimated Study Completion Date: August 2016
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregabalin (Lyrica)
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.
Drug: Pregabalin (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.
Other Name: Lyrica
Placebo Comparator: Placebo
Placebo, not active
Drug: Placebo
A matching placebo will be administered twice a day
Other Name: Lyrica

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.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00977197

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Wisconsin
Mayo Clinic Health System - Franciscan Healthcare in La Crosse
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Mayo Clinic
  More Information

Additional Information:
Responsible Party: Yuri A. Saito Loftus, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00977197     History of Changes
Other Study ID Numbers: 09-004404 
Study First Received: September 11, 2009
Last Updated: September 29, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Anti-Anxiety Agents
Calcium Channel Blockers
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 26, 2016