Clinical trial NCT00977197: A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Official title: A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-09-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
timeFrame: weeks 9-12
Secondary outcomes:
measure: Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
timeFrame: weeks 9-12
measure: Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)
timeFrame: Weeks 9-12
measure: Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
timeFrame: Weeks 9-12
measure: Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
timeFrame: Weeks 9-12)
measure: Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
timeFrame: Weeks 9-12
measure: Mean Pain BSS Score at Week 12
timeFrame: Week 12
measure: Mean Overall Severity BSS Score at Week 12
timeFrame: Week 12
measure: Mean Constipation BSS Score at Week 12
timeFrame: Week 12
measure: Mean Diarrhea BSS Score at Week 12
timeFrame: Week 12
measure: Mean Bloating BSS Score at Week 12
timeFrame: Week 12
measure: Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
timeFrame: baseline, week 12
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: La Crosse
country: United States
facility: Mayo Clinic Health System - Franciscan Healthcare in La Crosse
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Yuri A Saito Loftus, MD
role: PRINCIPAL_INVESTIGATOR
References: