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Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

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ClinicalTrials.gov Identifier: NCT00553592
Recruitment Status : Unknown
Verified November 2007 by XTL Biopharmaceuticals.
Recruitment status was:  Recruiting
First Posted : November 5, 2007
Last Update Posted : November 5, 2007
Sponsor:
Information provided by:
XTL Biopharmaceuticals

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Drug: Bicifadine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Drug
Bicifadine
Drug: Bicifadine
600mg/day
Experimental: Drug: 2
Bicifadine
Drug: Bicifadine
1200 mg
Placebo Comparator: Control
Placebo of Bicifadine
Drug: Bicifadine
placebo tablet



Primary Outcome Measures :
  1. Pain and Safety [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00553592     History of Changes
Other Study ID Numbers: XTL B07-001
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: November 5, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Diabetic Neuropathies
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases