NCT01089855

Brief Summary

The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

July 13, 2017

Status Verified

February 1, 2011

Enrollment Period

7 months

First QC Date

March 17, 2010

Last Update Submit

July 10, 2017

Conditions

Neuropathic Pain

Keywords

Neuropathic PainBrief Pain InventoryDN4 questionnaireElectroCardioGram

Outcome Measures

Primary Outcomes (1)

  • The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)

    12 weeks

Secondary Outcomes (2)

  • Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)

    12 weeks

  • Evaluate the quality of life

    12 weeks

Study Arms (1)

Carbamazepine

EXPERIMENTAL
Drug: Carbamazepine

Interventions

CarbamazepineDRUG
Carbamazepine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigational Site

Rabat, Morocco

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 19, 2010

Study Start

December 1, 2009

Primary Completion

July 1, 2010

Last Updated

July 13, 2017

Record last verified: 2011-02

Locations

MO(1)