Back to resultsPregabalin for Abdominal Pain From Adhesions
Primary Purpose
Abdominal Pain, Surgical Adhesions
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
Placebo first followed by open label pregabalin
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Pain focused on measuring abdominal pain, surgical adhesions
Eligibility 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
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions
Arm Description
Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00310765
First Posted
March 31, 2006
Last Updated
September 26, 2023
Sponsor
Henry Ford Health System
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00310765
Brief Title
Pregabalin for Abdominal Pain From Adhesions
Official Title
Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated by the sponsor due to low accrual.
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Surgical Adhesions
Keywords
abdominal pain, surgical adhesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Patients were evaluated for the study and were entered into the study if they had documented abdominal adhesions and a daily pain score of 40 mm on a visual assessment scale and 4 on an eleven point Likert scale (0 none and 10 most pain). Patients were randomly assigned to active drug or look alike placebo for 7 weeks followed by an open label phase in which all patients received active drug pregabalin 300 mg daily for 4 weeks measuring pain and sleep scores during each phase of the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinding was done to ensure minimum bias. Clinicians were not involved in the randomization process. Patients and clinicians were blinded to the identity of the drug as a look alike placebo was used. The randomization code was was maintained by the research assistant and kept in a locked file cabinet. Separated individuals generated the allocation sequence. The blind was maintained until all the decisions regarding data evaluability were made or in the event of a serious adverse event.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin 150 or 300 mg daily for severe abdominal pain from adhesions
Arm Type
Active Comparator
Arm Description
Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Arm Title
Look alike placebo 150 or 300 mg daily for severe abdominal pain from adhesions
Arm Type
Placebo Comparator
Arm Description
Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks
Other Intervention Name(s)
Lyrica
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo first followed by open label pregabalin
Other Intervention Name(s)
Look alike placebo followed by open label pregabalin, Lyrica
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and week 2 through week 12
Secondary Outcome Measure Information:
Title
Improved Sleep Scores
Description
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
Time Frame
Baseline and week 2 through week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann L Silverman, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22020082
Citation
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.
Results Reference
result
Learn more about this trial
Pregabalin for Abdominal Pain From Adhesions
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