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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00977197
First received: September 11, 2009
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


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 ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 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 Drug: Placebo
A matching placebo will be administered twice a day

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977197

Contacts
Contact: Annie E Almazar (507) 284-5010 almazar.ann@mayo.edu
Contact: Katherine Tilkes (507) 538-7948 tilkes.katherine@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Annie Almazar    507-284-5010    almazar.ann@mayo.edu   
Principal Investigator: Yuri A. Saito Loftus, M.D., M.P.H.         
United States, Wisconsin
Mayo Clinic Health System - Franciscan Healthcare in La Crosse Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Sharon Schulz, RN    608-392-4180      
Principal Investigator: Michael Van Norstrand, MD         
Sponsors and Collaborators
Mayo Clinic
Pfizer
  More Information

Additional Information:
No publications provided

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: March 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014