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A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Primary Purpose

Painful Diabetic Peripheral Neuropathy

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GRC 17356

Matching Placebo

About this trial

This is an interventional treatment trial for Painful Diabetic Peripheral Neuropathy focused on measuring Diabetic neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients willing to provide voluntary written informed consent
Male and female patients ≥18 yrs and ≤75 yrs
Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months
A baseline 24-hour average daily pain intensity score ≥5
Women must be of non child-bearing potential, defined as post menopausal or surgically sterile

Exclusion Criteria:

Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
Other causes of neuropathy or lower extremity pain
Complex regional pain syndrome or trigeminal neuralgia
Lower extremity amputations other than toes
Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study
Major depression.
Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigator's medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patient's safety or study outcome

Sites / Locations

NeuroHelp s.r.o
DADO Medical s.r.o
DADO Medical s.r.o
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Bangalore Clinisearch
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Jnana Sanjeevani Medical Centre
TOTALL Diabetes Hormone Institute
Jehangir Clinical development Centre Pvt Ltd
Getwell Hospital and Research Centre
MV Hospital for Diabetes (P) Ltd
Kovai Diabetes Speciality Centre and Hospital
Arthur Asirvathma Hospital
Maulana Azad Medical College & Associate Hospitals
ICON Manchester CPU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test Arm

Placebo

Arm Description

GRC17356 for daily administration

Matching placebo for daily administration

Outcomes

Primary Outcome Measures

Mean 24-hour average pain intensity (API) score.

Secondary Outcome Measures

Mean night-time API Score

Patient Global Impression of Change

Clinician Global Impression of Change

Full Information

NCT ID

NCT01726413

First Posted

November 9, 2012

Last Updated

October 1, 2014

Sponsor

Glenmark Pharmaceuticals Ltd. India

Collaborators

Glenmark Pharmaceuticals S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01726413

Brief Title

A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).

Official Title

A Phase II, 4-Week Randomised, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Glenmark Pharmaceuticals Ltd. India

Collaborators

Glenmark Pharmaceuticals S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Peripheral Neuropathy

Keywords

Diabetic neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test Arm

Arm Type

Experimental

Arm Description

GRC17356 for daily administration

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo for daily administration

Intervention Type

Drug

Intervention Name(s)

GRC 17356

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Primary Outcome Measure Information:

Title

Mean 24-hour average pain intensity (API) score.

Time Frame

Week 4

Secondary Outcome Measure Information:

Title

Mean night-time API Score

Time Frame

4 weeks

Title

Patient Global Impression of Change

Time Frame

4 weeks

Title

Clinician Global Impression of Change

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients willing to provide voluntary written informed consent Male and female patients ≥18 yrs and ≤75 yrs Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months A baseline 24-hour average daily pain intensity score ≥5 Women must be of non child-bearing potential, defined as post menopausal or surgically sterile Exclusion Criteria: Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain Other causes of neuropathy or lower extremity pain Complex regional pain syndrome or trigeminal neuralgia Lower extremity amputations other than toes Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study Major depression. Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigator's medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patient's safety or study outcome

Overall Study Officials: