| Criteria: |
|
Inclusion Criteria:
- Established diagnosis of IBS
- Meet Rome III diagnostic criteria for IBS
- 50/100 or greater of pain or discomfort BSS 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) |