Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy - Tabular View

Tracking Information
First Received Date ^ICMJE	June 9, 2005
Last Updated Date	December 26, 2007
Start Date ^ICMJE	July 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Pain rating scale obtained from patient diaries
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00113620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Additional diary rating scales and scores obtained from clinic visits
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy
Official Title ^ICMJE	A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy
Brief Summary	The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pain Diabetic Neuropathy
Intervention ^ICMJE	Drug: Neurodex
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	450
Completion Date	December 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of diabetes mellitus Established diabetic therapy for at least 3 months Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy Pain the previous three months Not pregnant Exclusion Criteria: Patient failed adequate trial of 3 or more medications or has required narcotics for pain History of torsades de pointes Sensitivity to quinidine or opiate drugs (codeine, etc) Severe pain that could confound the assessment Patient has had any amputations Patient has participated in the past 30 days or is currently participating in another trial Patient has previously received treatment with dextromethorphan and quinidine
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00113620
Responsible Party
Study ID Numbers ^ICMJE	04-AVR-109
Study Sponsor ^ICMJE	Avanir Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Avanir Pharmaceuticals
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP