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

NCT00977197

Last updated date
Study Location
Mayo Clinic
Rochester, Minnesota, 55905, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Irritable Bowel Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Advanced Information
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, MDMayo 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