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

Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: Pregabalin (Lyrica) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Mayo Clinic

Overall contact:
Annie E Almazar, Phone: (507)284-5010, Email: almazarelder.ann@mayo.edu

Summary

This study is being done to see if Lyrica helps people with irritable bowel syndrome, otherwise known as "IBS". 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 IBS-related conditions such as fibromyalgia.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To compare the effect of Pregabalin and placebo on self-reported overall and individual BSS scores

compare effect of Pregabalin and placebo on adequate relief of IBS pain or discomfort at least 50% of the time

To compare effect of Pregabalin and placebo on overall and individual BSS scores

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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, 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, pelvic floor dysfunction, paraplegia or quadriplegia); Known alternative/concurrent gastrointestinal diagnosis (e. g. Crohn's disease, ulcerative colitis, microscopic colitis, 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, pelvic floor dysfunction, paraplegia or quadriplegia)

- Current symptoms of severe depression, as measured by Hospital Anxiety and Depression

Scale (HADS) score >=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)

- Antidepressants (including TCAs, SSRIs, and SNRIs)

- 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.

- Non-narcotic anti-pain medications (e. g. NSAIDs, ultram, neurontin, etc.)

- Mexiletine, steroids, dextromethorphan.

- 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)

Locations and Contacts

Annie E Almazar, Phone: (507)284-5010, Email: almazarelder.ann@mayo.edu

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Annie Almazar, Phone: 507-284-5010, Email: almazar.ann@mayo.edu
Yuri A. Saito Loftus, M.D., M.P.H., Principal Investigator

Mayo Clinic Health System - Franciscan Healthcare in La Crosse, La Crosse, Wisconsin 54601, United States; Recruiting
Sharon Schulz, RN, Phone: 608-392-4180
Michael Van Norstrand, MD, Principal Investigator

Additional Information

Mayo Clinic Clinical Trials

Starting date: March 2010
Last updated: January 17, 2013

Page last updated: February 07, 2013

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