- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210847
A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy
Study Overview
Status
Conditions
Intervention / Treatment
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 different mechanisms of action, to provide the best pain relief. The pain-relieving potential of tramadol HCl /acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Patients who experience painful diabetic neuropathy will be enrolled. There will be a period of up to 3 weeks during which patients will stop taking medications not allowed by the study. A 7-day baseline period will follow, during which time patients will call into an Interactive Voice Response (IVR) system every night at bedtime to record daily assessments including average daily pain and sleep interference. Patients who enter the double-blind portion of the study will be randomized (like with the toss of a coin) to receive either tramadol HCl/acetaminophen or placebo. The dose of tramadol HCl/acetaminophen or placebo will be gradually increased until the doctor determines the patient is taking an adequate dose; up to 1 or 2 tablets 4 times per day, but not more than 8 tablets per day. Every night at bedtime during the double-blind phase, patients will call the IVR system to report assessments of average daily pain, sleep interference and the number of tablets of study medication taken that day. At the end of the study, patients will be tapered off their study medication. The objective of this study is to compare the analgesic effectiveness and safety of tramadol HCl/acetaminophen versus placebo for the treatment of painful diabetic neuropathy.
1 or 2 tramadol HCl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or matching placebo by mouth up to 4 times a day for 66 days
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change in the average of daily pain score recorded in the IVR system from baseline to the patient's final week of treatment with study medication.
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Secondary Outcome Measures
Outcome Measure |
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Efficacy measured by Brief Pain Inventory, Visual Analogue Scale, Short-Form McGill Pain Questionnaire, Profile of Mood States, SF-36 Health Survey, Physician and Subject Global Impression of Change, average daily sleep interference
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Tramadol
Other Study ID Numbers
- CR004660
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Neuropathies
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AstraZenecaCompletedDiabetic Neuropathy, Painful; Diabetic NeuropathiesUnited States
-
Maastricht University Medical CenterCompletedPainful Diabetic Neuropathy | Diabetic Neuropathies, Painful | Neuralgia, DiabeticNetherlands
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WinSanTor, IncCompletedPeripheral Neuropathy | Painful Diabetic Neuropathy | Diabetic Neuropathies, PainfulCanada
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Helixmith Co., Ltd.CompletedPainful Diabetic NeuropathiesUnited States, Korea, Republic of
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Imperial College LondonActegy Ltd.Not yet recruitingDiabetic Neuropathies | Diabetic Peripheral Neuropathy | Diabetic Polyneuropathy | Diabetic ComplicationUnited Kingdom
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Corporacion Parc TauliCompletedDiabetic Neuropathy | Diabetic Nerve Problems | Diabetic Complications NeurologicalPakistan
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University Medical Centre LjubljanaUnknown
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Timothy J. Best Medicine Professional CorporationThe Physicians' Services Incorporated FoundationCompleted
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AbbVie (prior sponsor, Abbott)CompletedDiabetic Neuropathies | Diabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Neuralgia, DiabeticUnited States, Canada, France, Germany, Italy, Mexico, Puerto Rico
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Eva PharmaMARC-CRORecruiting
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