Pregabalin for Abdominal Pain From Adhesions

Pregabalin for Abdominal Pain From Adhesions
This study is currently recruiting patients.
Verified by Henry Ford Health System December 2005
Sponsors and Collaborators:
Henry Ford Health System
Pfizer
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:NCT00310765
Purpose
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug.
During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin.

Condition
Intervention
Phase
Chronic Abdominal Pain Secondary to Surgical Adhesions
Drug: Pregabalin
Phase IV
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
Further study details as provided by Henry Ford Health System:
Expected Total Enrollment: 100
Study start: March 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years
must have undergone an evaluation to exclude other causes of abdominal pain
abdominal pain must be present for greater than three months duration
Exclusion Criteria:
patients that are pregnant or breast feeding
prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs
patients who are immunocompromised
patients with significant hepatic or renal insufficiency, or any significant hematologic disorder
history of illicit alcohol or drug abuse within one year
documented serious or unstable medical or psychological condition
malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin
Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00310765
Helen Gikas, RN, BSN 248-661-7928
hgikas1@hfhs.org
Michigan Henry Ford Health System, West Bloomfield, Michigan, 48322, United States; Recruiting
Helen Gikas, RN, BSN 248-661-7928
hgikas1@hfhs.org Ann L Silverman, MD, Principal Investigator
Study chairs or principal investigators
Ann L Silverman, MD, Principal Investigator, Henry Ford Health System
More Information
Study ID Numbers: 3727Last Updated: April 3, 2006Record first received: March 31, 2006ClinicalTrials.gov
Identifier: NCT00310765Health Authority: United States: Institutional Review BoardClinicalTrials.gov processed this record on 2006-04-07

http://www.clinicaltrials.gov/ct/show/NCT00310765;jsessionid=80DA8829BAC946C265C8AE64FA76556C?order=4