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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

Page last updated: August 08, 2008

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