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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00507936 |
This study will compare the efficacy and the safety of ABT-894 (1mg, 2mg or 4mg capsules) administered BID to placebo in the treatment of DNP. Another treatment arm will be Duloxetine 60mg administered once daily (QD).
Approximately 275 subjects will be enrolled into the study at approximately 50 sites in both the United States and Europe.
The study will be divided into the following periods: Screening/Washout (21 days) followed by a Baseline Visit, an 8-week Treatment Period and a 1-week Follow-up Visit.
Condition | Intervention | Phase |
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Diabetic Neuropathy, Painful Diabetic Polyneuropathy Neuralgia, Diabetic Diabetic Neuralgia Diabetic Neuropathies |
Drug: ABT-894 Drug: placebo Drug: duloxetine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Global, Multicenter, Randomized, Double-Blind, Placebo Controlled Study Comparing the Safety and Efficacy of ABT-894, Duloxetine and Placebo in Subjects With Diabetic Neuropathic Pain |
Enrollment: | 280 |
Study Start Date: | July 2007 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
ABT-894 1 mg BID
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Drug: ABT-894
ABT-894 1 mg capsule BID throughout treatment period
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B: Experimental
ABT-894 2 mg BID
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Drug: ABT-894
ABT-894 2 mg capsule BID throughout treatment period
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C: Experimental
ABT-894 4 mg BID
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Drug: ABT-894
ABT-894 4 mg capsule BID throughout treatment period
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D: Placebo Comparator |
Drug: placebo
placebo capsule BID throughout the treatment period
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E: Active Comparator
Duloxetine 60 mg QD
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Drug: duloxetine
duloxetine HC1 delayed release capsules, containing 60 mg equivalent to duloxetine base QD (morning dose active drug, evening dose is placebo)
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Wolfram Nothaft, MD | Abbott |
Responsible Party: | Abbott ( Wolfram Nothaft, MD ) |
Study ID Numbers: | M06-850 |
Study First Received: | July 25, 2007 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00507936 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetic Neuropathy, Painful Diabetic Polyneuropathy Neuralgia, Diabetic Diabetic Neuralgia Diabetic Neuropathies |
Dopamine Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Diabetic Neuropathies Neuralgia Psychotropic Drugs Polyneuropathies Diabetes Mellitus Endocrine System Diseases Pain Serotonin Uptake Inhibitors |
Serotonin Duloxetine Signs and Symptoms Dopamine Neuromuscular Diseases Peripheral Nervous System Diseases Neurologic Manifestations Dopamine Agents Endocrinopathy Antidepressive Agents Diabetes Complications |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Pain Duloxetine Signs and Symptoms Neuromuscular Diseases Therapeutic Uses Diabetes Complications |
Antidepressive Agents Neuralgia Diabetic Neuropathies Nervous System Diseases Diabetes Mellitus Polyneuropathies Endocrine System Diseases Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Peripheral Nervous System Diseases Neurologic Manifestations Dopamine Agents Central Nervous System Agents |