Abdominal Pain Clinical Trial
Official title:
Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
NCT number | NCT00310765 |
Other study ID # | 3727 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2006 |
Est. completion date | August 2008 |
Verified date | September 2023 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.
Status | Terminated |
Enrollment | 18 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Health System | West Bloomfield | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System | Pfizer |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication. | Baseline and week 2 through week 12 | |
Secondary | Improved Sleep Scores | Absolute Improvement in Sleep by assessing Mean Daily sleep interference scores as measured weekly starting at baseline and reported weekly through week 12 excluding the first week. This score is an 11 point scale the documents the pain interference in sleep in the preceding 24 hours. 0 is no interference and 10 is pain completely disrupted sleep in the previous 24 hours. During the study patients recorded a daily sleep interference score based on 11 point scale (0-10) with the higher number being the most sleep interference | Baseline and week 2 through week 12 |
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