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Pregabalin for Abdominal Pain From Adhesions

This study has been terminated.
(Study was terminated by the sponsor due to low accrual.)
Information provided by (Responsible Party):
Ann L. Silverman, Henry Ford Health System Identifier:
First received: March 31, 2006
Last updated: September 4, 2012
Last verified: September 2012
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Condition Intervention Phase
Abdominal Pain
Surgical Adhesions
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial

Resource links provided by NLM:

Further study details as provided by Ann L. Silverman, Henry Ford Health System:

Primary Outcome Measures:
  • Reduction in abdominal pain. [ Time Frame: 7 weeks ]
    Pain reduction as measured on a Likert scale.

Secondary Outcome Measures:
  • Improved sleep scores [ Time Frame: 7 weeks ]
    Improvement in Sleep by assessing Mean Daily sleep interference scores

Enrollment: 18
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
75-150 mg of pregabalin po BID
Drug: Pregabalin
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
Other Name: Look alike placebo 75 mg po BID. Increase to 150 mg if no improvement after 3 days.
Placebo Comparator: 2
Placebo 75 or 150 mg po BID
Drug: Pregabalin
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
Other Name: Look alike placebo 75 mg po BID. Increase to 150 mg if no improvement after 3 days.
Drug: Pregabalin
75 mg po BID
Other Name: gabapentin

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00310765

United States, Michigan
Henry Ford Health System
West Bloomfield, Michigan, United States, 48322
Sponsors and Collaborators
Henry Ford Health System
Principal Investigator: Ann L Silverman, MD Henry Ford Health System
  More Information

Responsible Party: Ann L. Silverman, DIRECTOR OF GI RESEARCH, Henry Ford Health System Identifier: NCT00310765     History of Changes
Other Study ID Numbers: 3727
Study First Received: March 31, 2006
Last Updated: September 4, 2012

Keywords provided by Ann L. Silverman, Henry Ford Health System:
abdominal pain
surgical adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Abdominal Pain
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on May 25, 2017