- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977197
A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Wisconsin
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La Crosse, Wisconsin, United States, 54601
- Mayo Clinic Health System - Franciscan Healthcare in La Crosse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pregabalin
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. |
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.
Other Names:
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Placebo Comparator: Placebo
Subjects randomized to this arm will receive placebo matching the study drug.
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A matching placebo will be administered twice a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12)
Time Frame: 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.
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weeks 9-12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12)
Time Frame: 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.
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weeks 9-12
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Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12)
Time Frame: 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.
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Weeks 9-12
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Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
Time Frame: 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
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Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12)
Time Frame: 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)
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Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy
Time Frame: Weeks 9-12
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One of the weekly questions asked of subjects was, "Did you have adequate relief of your IBS symptoms over the last week?"
Possible answers were Yes or No.
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Weeks 9-12
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Mean Pain BSS Score at Week 12
Time Frame: Week 12
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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.
|
Week 12
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Mean Overall Severity BSS Score at Week 12
Time Frame: Week 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.
|
Week 12
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Mean Constipation BSS Score at Week 12
Time Frame: Week 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.
|
Week 12
|
Mean Diarrhea BSS Score at Week 12
Time Frame: Week 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.
|
Week 12
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Mean Bloating BSS Score at Week 12
Time Frame: Week 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.
|
Week 12
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Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score
Time Frame: baseline, week 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.
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baseline, week 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yuri A Saito Loftus, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- 09-004404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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