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Trial record 1 of 1 for:    NCT00977197
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A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT00977197
Recruitment Status : Completed
First Posted : September 15, 2009
Results First Posted : July 14, 2016
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 15, 2009
Results First Submitted Date  ICMJE June 6, 2016
Results First Posted Date  ICMJE July 14, 2016
Last Update Posted Date October 28, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
The primary aim of this study is to collect preliminary data by comparing the effects of Pregabalin and placebo on the abdominal pain or discomfort score of BSS, overall BSS score, and adequate relief of IBS symptoms in patients with IBS. [ Time Frame: weekly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy [ Time Frame: Weeks 9-12 ]
    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.
  • Mean Pain 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • To compare the effect of Pregabalin and placebo on self-reported overall and individual BSS scores [ Time Frame: Last 4 weeks of treatment ]
  • compare effect of Pregabalin and placebo on adequate relief of IBS pain or discomfort at least 50% of the time [ Time Frame: During the last 4 weeks of therapy ]
  • To compare effect of Pregabalin and placebo on overall and individual BSS scores [ Time Frame: Week 12 ]
  • 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 [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Official Title  ICMJE A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Brief Summary This study is being done to see if Lyrica helps people with irritable bowel syndrome.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Pregabalin
    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 Name: Lyrica
  • Drug: Placebo
    A matching placebo will be administered twice a day
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Subjects randomized to this arm will receive placebo matching the study drug.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
85
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
100
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977197
Other Study ID Numbers  ICMJE 09-004404
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yuri A. Saito Loftus, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Yuri A Saito Loftus, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP