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:
Information provided by:
XTL Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00597649
First received: January 9, 2008
Last updated: June 29, 2009
Last verified: June 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

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

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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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: January 9, 2008
Last Updated: June 29, 2009
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

Additional relevant MeSH terms:
Neuralgia
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Pain
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014