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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00977197
• Other study ID #: 09-004404
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 11, 2009
• Last updated: September 29, 2015
• Start date: March 2010
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: August 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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, 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.

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)

Study Design

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.
• Placebo
A matching placebo will be administered twice a day

Locations

Country	Name	City	State
United States	Mayo Clinic Health System - Franciscan Healthcare in La Crosse	La Crosse	Wisconsin
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		weekly	No
Secondary	To compare the effect of Pregabalin and placebo on self-reported overall and individual BSS scores		Last 4 weeks of treatment	No
Secondary	compare effect of Pregabalin and placebo on adequate relief of IBS pain or discomfort at least 50% of the time		During the last 4 weeks of therapy	No
Secondary	To compare effect of Pregabalin and placebo on overall and individual BSS scores		Week 12	No
Secondary	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		12 weeks	No

External Links

•   Mayo Clinic Clinical Trials