Pregabalin for Abdominal Pain From Adhesions

NCT00310765 | Terminated Phase 4 Results

• 1 other identifier: 3727
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Pain; Surgical Adhesions

Keywords

abdominal pain; surgical adhesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improved Sleep Scores

  Baseline and week 2 through week 12

Study Arms (2)

Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions

ACTIVE COMPARATOR

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

Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions

PLACEBO COMPARATOR

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; Drug: Placebo first followed by open label pregabalin

Interventions

Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks DRUG

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

Also known as: Lyrica

Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions; Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions

Placebo first followed by open label pregabalin DRUG

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.

Also known as: Look alike placebo followed by open label pregabalin, Lyrica

Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• Pfizer: collaborator

Study Sites (1)

Henry Ford Health System

West Bloomfield, Michigan, 48322, United States

Location

Related Publications (1)

• 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.

  PMID: 22020082 RESULT

MeSH Terms

Conditions

Abdominal Pain; Tissue Adhesions

Interventions

BID protein, human; Pregabalin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Cicatrix; Fibrosis; Pathologic Processes

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Difficult to find patients that met criteria for study entry. Study terminated due to low enrollment.

Results Point of Contact

• Title: Dr. Ann Silverman
• Organization: retired

anngimd@icloud.com

Study Officials

• Ann L Silverman, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinding was done to ensure minimum bias. Clinicians were not involved in the randomization process. Patients and clinicians were blinded to the identity of the drug as a look alike placebo was used. The randomization code was was maintained by the research assistant and kept in a locked file cabinet. Separated individuals generated the allocation sequence. The blind was maintained until all the decisions regarding data evaluability were made or in the event of a serious adverse event.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR OF GI RESEARCH

Model Details: Patients were evaluated for the study and were entered into the study if they had documented abdominal adhesions and a daily pain score of 40 mm on a visual assessment scale and 4 on an eleven point Likert scale (0 none and 10 most pain). Patients were randomly assigned to active drug or look alike placebo for 7 weeks followed by an open label phase in which all patients received active drug pregabalin 300 mg daily for 4 weeks measuring pain and sleep scores during each phase of the study.

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 4, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 23, 2023
• Results First Posted: October 23, 2023

Record last verified: 2023-09

Locations

US (1)