Status:
COMPLETED
A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of ne...
Detailed Description
Previous studies have shown that tramadol HCl is effective in painful diabetic neuropathy. The treatment of neuropathic pain often requires the use of more than one medication, working through differe...
Eligibility Criteria
Inclusion
- Diagnosis of diabetic neuropathy in both lower extremities
- Lower extremity pain for at least 3 months
- Stable treatment of diabetes with drugs or diet for at least 3 months
- Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of \<10%)
- Documented daily pain on at least 4 of 7 days during baseline period (pain rated at least 5 on scale of 11)
- In generally good health
- If female of childbearing potential, using acceptable method of birth control
Exclusion
- No failed trials of tramadol HCl or tramadol HCl/acetaminophen
- No participation in more than 2 clinical trials for treatment of neuropathic pain
- No more than 2 failed trials of medications for neuropathic pain
- No use of prohibited concomitant medications
- No peripheral neuropathy caused by condition other than diabetes
- No other pain more severe than neuropathic pain
- No progressive or degenerative neurological disorder
- No painful peripheral diabetic neuropathy for \> 10 years
- No kidney or liver dysfunction
- Not pregnant or breast-feeding
- No unstable medical disease
- No clinically significant medical conditions
- No condition that might affect the way the body absorbs or processes the study drug
- No history of suicide attempt/tendencies
- No major psychiatric disorder in past 6 months
- No history of drug or alcohol abuse/dependance in the past 2 years
- No amputations
- No active infection of the lower extremity
- No active foot ulcer
- No use of an investigational drug in past 30 days
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00210847
Start Date
December 1 2003
End Date
May 1 2005
Last Update
June 10 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.