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Sponsored by: |
Abbott |
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 |
Diabetic Neuropathy, Painful Diabetic Polyneuropathy Neuralgia, Diabetic Diabetic Neuralgia Diabetic Neuropathies |
Drug: ABT-894 Drug: placebo Drug: duloxetine |
Phase II |
MedlinePlus related topics: | Diabetic Nerve Problems |
ChemIDplus related topics: | Duloxetine Duloxetine hydrochloride |
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 |
Estimated Enrollment: | 275 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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: Sham 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:
Contact: Rachel Duan, MD, PhD | 847-937-3978 | wrachel.duan@abbott.com |
Contact: Traci Baker, BA | 847-936-6555 | traci.baker@abbott.com |
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Show 30 Study Locations |
Abbott |
Study Director: | Wolfram Nothaft, MD | Abbott |
Responsible Party: | Abbott ( Wolfram Nothaft, MD ) |
Study ID Numbers: | M06-850 |
First Received: | July 25, 2007 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00507936 |
Health Authority: | United States: Food and Drug Administration |
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