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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00553592
Other study ID # XTL B07-001
Secondary ID
Status Recruiting
Phase Phase 2
First received November 1, 2007
Last updated November 2, 2007
Start date September 2007
Est. completion date December 2008

Study information

Verified date November 2007
Source XTL Biopharmaceuticals
Contact Ivy Raso
Phone 845-267-0707
Email iraso@xtlbio.com
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIsrael: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesIndia: Drugs Controller General of India
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 336
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bicifadine
600mg/day
Bicifadine
placebo tablet
Bicifadine
1200 mg

Locations

Country Name City State
United States Four Rivers Clinical Research Paducah Kentucky

Sponsors (1)

Lead Sponsor Collaborator
XTL Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain and Safety 14 weeks
Secondary 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 14 weeks
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