Pregabalin for Abdominal Pain From Adhesions

Henry Ford Health

Status and phase: Terminated; Phase 4

Conditions: Surgical Adhesions; Abdominal Pain

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00310765

3727

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

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

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

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