Expired Study
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Paducah, Kentucky 42003


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.


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


Study is Available At:


Original ID:

XTL B07-001


NCT ID:

NCT00553592


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

XTL Biopharmaceuticals


Oversight 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


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

336


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Mark Roffman, PhD
Study Director
XTL Bio
Primary Contact:Ivy Raso
845-267-0707 ext. 222
845-267-0707
iraso@xtlbio.com
Backup Contact:Kevin Barnes, MT
512-306-4254
kbarnes@incresearch.com

Study Dates

Start Date:September 2007
Completion Date:December 2008
Completion Type:Anticipated
Verification Date:November 2007
Last Changed Date:November 2, 2007
First Received Date:November 1, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pain and Safety
Time Frame:14 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Bicifadine
Description:600mg/day
Arm Name:Drug
Intervention Type:Drug
Name:Bicifadine
Description:placebo tablet
Arm Name:Control
Intervention Type:Drug
Name:Bicifadine
Description:1200 mg
Arm Name:Drug: 2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Control
Description:Placebo of Bicifadine
Study Arm Type:Experimental
Arm Name:Drug: 2
Description:Bicifadine
Study Arm Type:Experimental
Arm Name:Drug
Description:Bicifadine

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:XTL Biopharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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