Efficacy and Tolerability of Carbamazepine CR in Diabetic... | NCT01089855

Studies
Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

NCT01089855

Sponsor

Novartis

Status

Completed

Last Update Posted

Jul 13, 2017Actual

Enrollment

123Actual

Phase

Phase 4

Conditions

Neuropathic Pain

Interventions

Carbamazepine

Countries

Morocco

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

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Not provided

First Submitted Date

Mar 17, 2010

First Submission Date that Met QC Criteria

Mar 18, 2010

First Posted Date

Mar 19, 2010Estimated

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

Jul 10, 2017

Last Update Posted Date

Jul 13, 2017Actual

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Label	Type	Description	Intervention Names
Carbamazepine	Experimental		Drug: Carbamazepine

Name	Type	Description	Arm Group Labels	Other Names
Carbamazepine	Drug		Carbamazepine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)		12 weeks
Evaluate the quality of life		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes patients with Diabetes neuropathy DN4 > or equal to 4
Male or female aged from 21 to 65 years
Informed consent
HbA1C < 11%

Exclusion Criteria:

Prior Hospitalization for Acido- cetosis
Prior hospitalization for severe hypoglycemia
Pregnancy
Hepatitis
Diabetes foot
AVB (auriculo-ventricular conduction disturbance)
Patient treated by antidepressant drugs
Patient treated with other antiepileptic drug
Patients with blood ion disturbance
Patient with neutropenia
Glaucoma
Bladder Adenoma
Alcohol abuse
Creatinin clearance < 60 ml/ minute

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigational Site		Rabat			Morocco

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002220	Carbamazepine

Ancestor Terms

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided