Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes - Full Text View

Sponsored by:	XTL Biopharmaceuticals
Information provided by:	XTL Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00553592

Purpose

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.

To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.

Condition	Intervention	Phase
Diabetic Peripheral Neuropathy	Drug: Bicifadine	Phase II

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Bicifadine Bicifadine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Further study details as provided by XTL Biopharmaceuticals:

Primary Outcome Measures:

Pain and Safety [ Time Frame: 14 weeks ]

Secondary Outcome Measures:

Clinical Global Impression of Improvement, McGill Pain Questionnaire, Amount of Rescue Medication Used for Pain, Quality of Life Survey (SF-36), Patient Global Impression of Change [ Time Frame: 14 weeks ]

Estimated Enrollment:	336
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
Drug: Experimental Bicifadine	Drug: Bicifadine 600mg/day
Drug: 2: Experimental Bicifadine	Drug: Bicifadine 1200 mg
Control: Placebo Comparator Placebo of Bicifadine	Drug: Bicifadine placebo tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, 18 years or older
Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus
Chronic bilateral pain due to diabetic neuropathy
Pain for at least six months
Primary pain is located in the feet
Others-contact site for information

Exclusion Criteria:

Symptoms of other painful conditions
Presence of amputations other than toes
Clinically significant psychiatric or other neurological disorder
Use of certain medications
Clinically important other diseases
Pregnancy
History of alcohol or narcotic abuse within two years
Others-contact site for information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553592

Contacts

Contact: Ivy Raso	845-267-0707 ext 222	iraso@xtlbio.com
Contact: Kevin Barnes, MT	512-306-4254	kbarnes@incresearch.com

Locations

United States, Kentucky
Four Rivers Clinical Research	Recruiting
Paducah, Kentucky, United States, 42003
Contact: Jesse Wallace, MD 270-441-4606 diargent@fourriversresearch.com
Contact: Caron Massey 270-441-4606 cmassey@fourriversresearch.com
Principal Investigator: Jesse Wallace, MD

Sponsors and Collaborators

XTL Biopharmaceuticals

Investigators

Study Director:

Mark Roffman, PhD

XTL Bio

More Information

Sponsor's website This link exits the ClinicalTrials.gov site

Study ID Numbers:	XTL B07-001
Study First Received:	November 1, 2007
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00553592
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; India: Drugs Controller General of India

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009