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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.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ann L. Silverman, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00310765
First received: March 31, 2006
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Reduction in abdominal pain. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Pain reduction as measured on a Likert scale.


Secondary Outcome Measures:
  • Improved sleep scores [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310765

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

Publications:

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

Keywords provided by Henry Ford Health System:
abdominal pain
surgical adhesions

Additional relevant MeSH terms:
Abdominal Pain
Tissue Adhesions
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Cicatrix
Fibrosis
Pathologic Processes
Pregabalin
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 19, 2013