Back to results

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

Primary Purpose

Painful Diabetic Neuropathy

Status

Withdrawn

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GRC 17536 (Medium Dose)

GRC 17536 (Low Dose)

Placebo

About this trial

This is an interventional treatment trial for Painful 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 (women of non child-bearing potential) 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

Site 2
Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Arm 1

Traetment Arm 2

Treatment Arm 3

Arm Description

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

Adverse events (AE)

Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24

Full Information

NCT ID

NCT01556152

First Posted

March 15, 2012

Last Updated

November 9, 2012

Sponsor

Glenmark Pharmaceuticals Ltd. India

Collaborators

Glenmark Pharmaceuticals S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01556152

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Due to new scientific evidence assessment, the study design was revised before the study started recruitment

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

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

Yes

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 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of painful DPN. Generally, 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. This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to DPN for least 6 months and no greater than 5 years. Patients will be recruited after providing written informed consent.

6. Conditions and Keywords

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

Painful Diabetic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm 1

Arm Type

Active Comparator

Arm Title

Traetment Arm 2

Arm Type

Active Comparator

Arm Title

Treatment Arm 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

GRC 17536 (Medium Dose)

Intervention Description

1 BD for 28 days

Intervention Type

Drug

Intervention Name(s)

GRC 17536 (Low Dose)

Intervention Description

1 BD for 28 Days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo for 28 Days

Primary Outcome Measure Information:

Title

Mean 24-hour average pain intensity (API) score

Time Frame

4 weeks

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

Title

Adverse events (AE)

Time Frame

4 weeks

Title

Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24

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 (women of non child-bearing potential) 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:

First Name & Middle Initial & Last Name & Degree

Dr. Kavita Muchandi, MD

Organizational Affiliation

Glenmark Pharmaceuticals Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Site 2

City

Mainz

Country

Germany

Facility Name

Site 1

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs