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

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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

Who is eligible to participate?

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, fecal incontinence, small bowel or colonic resection, unresolved or 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: - ACE inhibitors (e.g. Zestril, Altace, Lotensin) - 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)

What is involved?

The study involves one in-person visit (this visit). During this 1-hour visit, questions will be asked to determine whether you are suitable for this study and if it is safe for you to participate.  This will include asking about your symptoms, your medical history, medications, as well as your current mood.  A physician will perform an evaluation that will include a general physical examination.  If you are a woman of child-bearing age, a urine pregnancy test will also be performed to ensure that you are not unknowingly pregnant.  During the screening phase, we will ask you to record your symptoms for up to two weeks to evaluate the intensity of your IBS symptoms.  If, after the screening you are eligible and you agree to participate, you will start the treatment phase in approximately two weeks? time.

You will be put into one of two groups by chance (as in the flip of a coin).  A computerized selection process will be used to assign participants to the study groups that will receive either pregabalin or placebo (inactive medication).  Neither you nor the study personnel can choose which group you will be in, nor will you or they know which group you are assigned to until the study is over.  The two groups are required so that we can get a fair idea of what the effect of pregabalin is.  

Prior to the treatment phase, you will receive a packet containing surveys, daily diaries, and the study medication in the mail.  Shortly after, you will receive a phone call from a member of the study team to review the items in the packet.  During the 12-week treatment phase, you will take the recommended dosage of study medication two times a day (i.e. morning and night) and will complete and return a survey and daily diaries every week.  You will be called at a prescheduled date and time by a study team member who will provide guidance in completing the questionnaire.  Each survey will ask you about your gut symptoms, medication use, any missed doses, and about side effects.  Each mailed survey should take approximately 10 minutes to complete.  Reminder phone calls will be made if we have not received your weekly survey within a week or if questions arise upon reviewing your questionnaire.  

During this study, you will be asked not to take specific drugs for IBS, such as alosetron, tegaserod, pregabalin, or other herbal or dietary supplements for IBS, and from starting new treatments for IBS.  However, most other drugs for IBS that you are currently taking will be allowed, unless you have been told otherwise.  In addition, pregabalin interacts with some medications.  You should discuss these with your study doctor before taking any new medications.

When all participants have completed their participation and everyone?s data has been reviewed, the results of this study will be mailed to you in a summary newsletter.  Please note that this may be months to years after your active involvement.

How long is the study?

You will be in the study for a total of 12 weeks(approximately three months.

Last updated:

3/28/2014

NCT ID:

NCT00977197

IRB Number:

09-004404