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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date September 2023
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
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 and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID
Placebo first followed by open label pregabalin
Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.

Locations

Country Name City State
United States Henry Ford Health System West Bloomfield Michigan

Sponsors (2)

Lead Sponsor Collaborator
Henry Ford Health System Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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