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Trial record 1 of 1 for:    NCT00310765
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Pregabalin for Abdominal Pain From Adhesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310765
Recruitment Status : Terminated (Study was terminated by the sponsor due to low accrual.)
First Posted : April 4, 2006
Last Update Posted : September 5, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ann L. Silverman, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE March 31, 2006
First Posted Date  ICMJE April 4, 2006
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE March 2006
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Reduction in abdominal pain. [ Time Frame: 7 weeks ]
Pain reduction as measured on a Likert scale.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Improved sleep scores [ Time Frame: 7 weeks ]
Improvement in Sleep by assessing Mean Daily sleep interference scores
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pregabalin for Abdominal Pain From Adhesions
Official Title  ICMJE Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Pain
  • Surgical Adhesions
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    75-150 mg of pregabalin po BID
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Placebo 75 or 150 mg po BID
    Interventions:
    • Drug: Pregabalin
    • Drug: Pregabalin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
18
Original Enrollment  ICMJE
 (submitted: March 31, 2006)
100
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00310765
Other Study ID Numbers  ICMJE 3727
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ann L. Silverman, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Ann L Silverman, MD Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP