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

NCT00977197 | Completed Phase 2 Results

• 1 other identifier: 09-004404
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)

  The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value.

  weeks 9-12

Secondary Outcomes (11)

• Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)

  weeks 9-12

• Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)

  Weeks 9-12

• Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)

  Weeks 9-12

• Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)

  Weeks 9-12)

• Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy

  Weeks 9-12

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Subjects randomized to this arm will receive the following dosage: 75 mg (one tablet) 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.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Subjects randomized to this arm will receive placebo matching the study drug.

Drug: Placebo

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

Pregabalin

Placebo DRUG

A matching placebo will be administered twice a day

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of Irritable Bowel Syndrome (IBS)
• Experience pain with relief with defecation
• /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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Pfizer: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System - Franciscan Healthcare in La Crosse

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Yuri A. Saito Loftus, M.D.
• Organization: Mayo Clinic

saito.yuri@mayo.edu

507-284-2687

Study Officials

• Yuri A Saito Loftus, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 15, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 28, 2016
• Results First Posted: July 14, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)