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A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

This study has been terminated.
(The 001 trial did not show benefit versus placebo)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597649
First Posted: January 18, 2008
Last Update Posted: June 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
XTL Biopharmaceuticals
  Purpose
This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.

Condition Intervention Phase
Chronic Peripheral Neuropathy Pain in Diabetics Drug: Bicifadine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by XTL Biopharmaceuticals:

Primary Outcome Measures:
  • Pain and safety [ Time Frame: one year ]

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: One year ]

Estimated Enrollment: 250
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bicifadine 800 mg/day for a year
Drug: Bicifadine
SR dosage form of 400 mg bid or tid for one year
Experimental: 2
Bicifadine 1200 mg/day for a year
Drug: Bicifadine
SR dosage form of 400 mg bid or tid for one year

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (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.
  • Subject participated in and completed the XTL 07-001 clinical trial.

Contact site for additional information.

Exclusion Criteria:

  • Symptoms of other painful conditions
  • Presence of amputations other than toes
  • Clinically significant psychiatric or other neuropsychological disorder
  • Use of certain medications
  • Clinically important other diseases
  • Pregnancy
  • History of alcohol or narcotic abuse within two years.

Contact site for additional information.

  Contacts and Locations
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): NCT00597649


Locations
United States, Kentucky
Four Rivers Clinical Research
Paducah, Kentucky, United States
Sponsors and Collaborators
XTL Biopharmaceuticals
Investigators
Study Director: Mark Roffman, PhD XTL Biopharmaceuticals
  More Information

Additional Information:
Responsible Party: Mark Roffman, Vice President, XTL Biopharmaceutical Co.
ClinicalTrials.gov Identifier: NCT00597649     History of Changes
Other Study ID Numbers: XTL B07-002
2007-003638-40
First Submitted: January 9, 2008
First Posted: January 18, 2008
Last Update Posted: June 30, 2009
Last Verified: June 2009

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