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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)

NCT ID: NCT01556152

Last Updated: 2012-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Painful Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Arm 1

Group Type ACTIVE_COMPARATOR

GRC 17536 (Medium Dose)

Intervention Type DRUG

1 BD for 28 days

Traetment Arm 2

Group Type ACTIVE_COMPARATOR

GRC 17536 (Low Dose)

Intervention Type DRUG

1 BD for 28 Days

Treatment Arm 3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo for 28 Days

Interventions

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GRC 17536 (Medium Dose)

1 BD for 28 days

Intervention Type DRUG

GRC 17536 (Low Dose)

1 BD for 28 Days

Intervention Type DRUG

Placebo

Matching Placebo for 28 Days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
2. Other causes of neuropathy or lower extremity pain
3. Complex regional pain syndrome or trigeminal neuralgia
4. Lower extremity amputations other than toes
5. 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
6. Major depression.
7. 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.
8. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glenmark Pharmaceuticals S.A.

INDUSTRY

Sponsor Role collaborator

Glenmark Pharmaceuticals Ltd. India

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Kavita Muchandi, MD

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals Ltd

Locations

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Site 2

Mainz, , Germany

Site Status

Site 1

Manchester, , United Kingdom

Site Status

Countries

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Germany United Kingdom

Other Identifiers

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2011-005879-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GRC 17536-201

Identifier Type: -

Identifier Source: org_study_id