Double Blind RCT of Bicifadine SR in Outpatients With Chr... | NCT00553592

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

NCT00553592

Sponsor

XTL Biopharmaceuticals

Status

Unknown status

Last Update Posted

Nov 5, 2007Estimated

Enrollment

336Estimated

Phase

Phase 2

Conditions

Diabetic Peripheral Neuropathy

Interventions

Bicifadine
Bicifadine
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

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Nov 1, 2007

First Submission Date that Met QC Criteria

Nov 2, 2007

First Posted Date

Nov 5, 2007Estimated

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

Nov 2, 2007

Last Update Posted Date

Nov 5, 2007Estimated

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

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.

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

336Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug	Experimental	Bicifadine	Drug: Bicifadine
Drug: 2	Experimental	Bicifadine	Drug: Bicifadine
Control	Placebo Comparator	Placebo of Bicifadine	Drug: Bicifadine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bicifadine	Drug	600mg/day	Drug
Bicifadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain and Safety		14 weeks

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		14 weeks

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ivy Raso	Contact	845-267-0707	222	iraso@xtlbio.com
Kevin Barnes, MT	Contact	512-306-4254		kbarnes@incresearch.com

Overall Officials

Name	Affiliation	Role
Mark Roffman, PhD	XTL Bio	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Four Rivers Clinical Research	Recruiting	Paducah	Kentucky	42003	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