ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | 18 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |