Clinical trial NCT00310765: Pregabalin for Abdominal Pain From Adhesions
Official title: Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Abdominal Pain
Surgical Adhesions
Keywords: abdominal pain
surgical adhesions
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2006-04-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline and week 2 through week 12
Secondary outcomes:
measure: Improved Sleep Scores
timeFrame: Baseline and week 2 through week 12
Other outcomes:
Locations:
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Ann L Silverman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.