Status:
TERMINATED
Pregabalin for Abdominal Pain From Adhesions
Lead Sponsor:
Henry Ford Health System
Collaborating Sponsors:
Pfizer
Conditions:
Abdominal Pain
Surgical Adhesions
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.
Detailed Description
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00310765
Start Date
March 1 2006
End Date
August 1 2008
Last Update
October 23 2023
Active Locations (1)
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1
Henry Ford Health System
West Bloomfield, Michigan, United States, 48322