A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
NCT00977197
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
- 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)
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Descriptive Information | ||||
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Brief Title ICMJE | A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome | |||
Official Title ICMJE | A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome | |||
Brief Summary | This study is being done to see if Lyrica helps people with irritable bowel syndrome. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Irritable Bowel Syndrome | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 85 | |||
Original Estimated Enrollment ICMJE | 100 | |||
Actual Study Completion Date ICMJE | June 2015 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00977197 | |||
Other Study ID Numbers ICMJE | 09-004404 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Yuri A. Saito Loftus, Mayo Clinic | |||
Study Sponsor ICMJE | Mayo Clinic | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Mayo Clinic | |||
Verification Date | September 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |