Phase 2 N=85 Randomized Triple-blind Treatment

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

Irritable Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00977197 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Jul 2016

Primary outcome: Primary: Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) — 25.3; 42.0 units on a scale — p=0.008

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pregabalin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)	25.3; 42.0	0.008 sig
SECONDARY Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)	26.5; 42.2	0.009 sig
SECONDARY Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)	25.8; 22.4	0.389
SECONDARY Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)	16.9; 31.8	0.049 sig
SECONDARY Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)	29.3; 43.6	0.044 sig
SECONDARY Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy	19; 16; 22; 28	0.350
SECONDARY Mean Pain BSS Score at Week 12	26.1; 43.3	0.020 sig
SECONDARY Mean Overall Severity BSS Score at Week 12	28.5; 44.2	0.024 sig
SECONDARY Mean Constipation BSS Score at Week 12	26.1; 23.6	0.417
SECONDARY Mean Diarrhea BSS Score at Week 12	15.6; 34.4	0.030 sig
SECONDARY Mean Bloating BSS Score at Week 12	26.3; 45.0	0.016 sig
SECONDARY Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score	26; 20; 15; 24	0.097

Summary

This study is being done to see if Lyrica helps people with irritable bowel syndrome.

Eligibility Criteria

Inclusion Criteria

Established diagnosis of Irritable Bowel Syndrome (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
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, 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:
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.
Non-narcotic anti-pain medications (e.g. nonsteroidal antiinflammatory drug (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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00977197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.