Pregabalin for Abdominal Pain From Adhesions

Phase 4

Terminated

Interventions: Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
Drug: Placebo first followed by open label pregabalin

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 study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions	Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks	Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions	Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks	Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions	Placebo first followed by open label pregabalin	Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.

Primary Outcome Measures

Name	Time	Method
Absolute Adhesional Abdominal Pain Score Assessed at Baseline Through Week 12 in Patients Treated With Pregabalin 150-300 mg Daily Compared With Patients Given Look Alike Placebo	Baseline and week 2 through week 12	Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication.

Secondary Outcome Measures

Name	Time	Method
Improved Sleep Scores	Baseline and week 2 through week 12	Absolute Improvement in Sleep by assessing Mean Daily sleep interference scores as measured weekly starting at baseline and reported weekly through week 12 excluding the first week. This score is an 11 point scale the documents the pain interference in sleep in the preceding 24 hours. 0 is no interference and 10 is pain completely disrupted sleep in the previous 24 hours. During the study patients recorded a daily sleep interference score based on 11 point scale (0-10) with the higher number being the most sleep interference