Pregabalin for Abdominal Pain From Adhesions
Information source: Henry Ford Health System
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abdominal Pain; Surgical Adhesions
Intervention: Placebo (Drug); Pregabalin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Henry Ford Health System Official(s) and/or principal investigator(s):
Ann L Silverman, MD, Principal Investigator, Affiliation: Henry Ford Health System
Overall contact:
Helen Gikas, RN, BSN, Phone: 248-661-7928, Email: hgikas1@hfhs.org
Summary
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.
Clinical Details
Official title: Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Reduction in abdominal pain.
Secondary outcome: Improved sleep scores
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
Helen Gikas, RN, BSN, Phone: 248-661-7928, Email: hgikas1@hfhs.org
Henry Ford Health System, West Bloomfield, Michigan 48322, United States; Recruiting
Helen Gikas, RN, BSN, Phone: 248-661-7928, Email: hgikas1@hfhs.org
Ann L Silverman, MD, Principal Investigator
Additional Information
Starting date: March 2006
Ending date: May 2009
Last updated: May 7, 2008
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