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Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01331213
First received: April 6, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

The general aim of the current study is to describe the effect of pregabalin on colonic and sensory functions in Adults with Constipation Predominant Irritable Bowel Syndrome.


Condition Intervention Phase
Irritable Bowel Syndrome
 Drug: Pregabalin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Effect of Pregabalin on Colonic Motor and Sensory Function in Adults With Irritable Bowel Syndrome With Predominant Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Colonic compliance [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    AML distension 0-60 mmHg, expressed as Pr 1/2 (pressure at half-maximum volume)

  • Colonic tone postprandially [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Postprandial change (over fasting) in colonic tone

  • Sensory thresholds for pain [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Change in Post-treatment Sensory thresholds for pain

  • Overall sensory ratings in response to 16, 24, 30 and 36 mmHg distensions. [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Change in Post-treatment overall sensory ratings in response to 16, 24, 30 and 36 mmHg distensions.


Secondary Outcome Measures:
  • Colonic tone [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Fasting colonic tone

  • Colonic motility index [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Evaluation of Postprandial colonic motility index

  • Sensory thresholds for first sensation and gas [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Change in Post-treatment sensory thresholds for first sensation and gas


Enrollment: 18
Study Start Date: April 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pregabalin
200mg
 Drug: Pregabalin
medication (FDA approved) at 200mg
Other Name: Lyrica
Placebo Comparator: Placebo Drug: Pregabalin
medication (FDA approved) at 200mg
Other Name: Lyrica

Detailed Description:

Specific aims of the protocol:

  1. To quantify the effect of a single administration of 200mg pregabalin on colonic sensory and motor functions in constipation predominant IBS adults.
  2. To assess the potential relationship between any analgesic properties of pregabalin and its effect on compliance in constipation predominant IBS adults.
  3. To estimate if pregabalin 200mg dose reduces colonic sensation ratings and increases pain thresholds by 50% related to placebo.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Male or females with Constipation Predominant IBS, age 18-65

Exclusion criteria:

  1. abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation,
  2. uncontrolled hypertension,
  3. use of medications that may interact with the study medication,
  4. use of any of the study medications within the past 30 days,
  5. pregnancy,
  6. history of chronic renal insufficiency (serum creatinine >1.5mg/dL) and
  7. psychiatric or psychologic dysfunction
  8. current pelvic floor dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331213

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael Camilleri, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01331213     History of Changes
Other Study ID Numbers: 11-000485
Study First Received: April 6, 2011
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Pregabalin
Irritable Bowel Syndrome
motor
 sensation
colon
human

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 22, 2013