Pregabalin for Abdominal Pain From Adhesions

Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Study Overview

• Status: Terminated
• Conditions: Abdominal Pain; Surgical Adhesions
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • West Bloomfield, Michigan, United States, 48322
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions; 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.	Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks; First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID; Other Names: Lyrica
Placebo Comparator: Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions; 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.	Drug: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks; First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID; Other Names: Lyrica; Drug: Placebo first followed by open label pregabalin; Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.; Other Names: Lyrica; Look alike placebo followed by open label pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and week 2 through week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Sleep Scores	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	Baseline and week 2 through week 12

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Pfizer
• Investigators: Principal Investigator: Ann L Silverman, MD, Henry Ford Health System

Publications and helpful links

General Publications

• Silverman A, Samuels Q, Gikas H, Nawras A. Pregabalin for the treatment of abdominal adhesion pain: a randomized, double-blind, placebo-controlled trial. Am J Ther. 2012 Nov;19(6):419-28. doi: 10.1097/MJT.0b013e318217a5f5.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: March 31, 2006
• First Submitted That Met QC Criteria: March 31, 2006
• First Posted (Estimated): April 4, 2006

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: abdominal pain; surgical adhesions
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Fibrosis; Cicatrix; Abdominal Pain; Tissue Adhesions; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: 3727