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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

September 11, 2009
March 28, 2014
March 2010
July 2015   (final data collection date for primary outcome measure)
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 ]
The primary aim of this study is to collect preliminary data by comparing the effects of Pregabalin and placebo on the abdominal pain or discomfort score of BSS, overall BSS score, and adequate relief of IBS symptoms in patients with IBS. [ Time Frame: weekly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00977197 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • 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
  • Drug: Placebo
    A matching placebo will be administered twice a day
  • 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.
    Intervention: Drug: Pregabalin (Lyrica)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2015
July 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact: Annie E Almazar (507) 284-5010 almazar.ann@mayo.edu
Contact: Katherine Tilkes (507) 538-7948 tilkes.katherine@mayo.edu
United States
 
NCT00977197
09-004404
No
Yuri A. Saito Loftus, Mayo Clinic
Mayo Clinic
Pfizer
Not Provided
Mayo Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP