A 52-Week Study of Bicifadine in Patients With Chronic Ne... | NCT00597649

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

NCT00597649

Sponsor

XTL Biopharmaceuticals

Status

Terminated

Last Update Posted

Jun 30, 2009Estimated

Enrollment

250Estimated

Phase

Phase 2

Conditions

Chronic Peripheral Neuropathy Pain in Diabetics

Interventions

Bicifadine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-003638-40

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The 001 trial did not show benefit versus placebo

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jan 9, 2008

First Submission Date that Met QC Criteria

Jan 17, 2008

First Posted Date

Jan 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2009

Last Update Posted Date

Jun 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Bicifadine 800 mg/day for a year	Drug: Bicifadine
2	Experimental	Bicifadine 1200 mg/day for a year	Drug: Bicifadine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bicifadine	Drug	SR dosage form of 400 mg bid or tid for one year	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain and safety		one year

Secondary Outcomes

Measure	Description	Time Frame
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		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Roffman, PhD	XTL Biopharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Four Rivers Clinical Research		Paducah	Kentucky		United States

Label	URL
Sponsor's website	View source

Intervention Browse Module

MeSH Terms

ID	Term
C034438	bicifadine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided