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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00977197
• Date of registration: 11/09/2009
• Primary sponsor: Mayo Clinic
• Public title: A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
• Scientific title: A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
• Date of first enrolment: March 2010
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00977197
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Annie E Almazar

• Name: Annie E Almazar

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Drug: Placebo

Drug: Pregabalin (Lyrica)

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

To compare effect of Pregabalin and placebo on overall and individual BSS scores [Time Frame: Week 12]

To compare the effect of Pregabalin and placebo on self-reported overall and individual BSS scores [Time Frame: Last 4 weeks of treatment]

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]

Secondary ID(s)

09-004404

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer