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).

Phase 2

Completed

• Conditions: Painful Diabetic Peripheral Neuropathy
• Interventions: Drug: GRC 17356; Drug: Matching Placebo

• Registration Number: NCT01726413
• Lead Sponsor: Glenmark Pharmaceuticals Ltd. India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-01
• Last Update Posted: 2014-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1. Patients willing to provide voluntary written informed consent
2. Male and female 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Arm	GRC 17356	GRC17356 for daily administration
Placebo	Matching Placebo	Matching placebo for daily administration

Primary Outcome Measures

Name	Time	Method
Mean 24-hour average pain intensity (API) score.	Week 4

Secondary Outcome Measures

Name	Time	Method
Mean night-time API Score	4 weeks
Patient Global Impression of Change	4 weeks
Clinician Global Impression of Change	4 weeks

Trial Locations

Locations (14)

Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A); 🇩🇪 Mainz, Germany

Bangalore Clinisearch; 🇮🇳 Bangalore, Karnataka, India

DADO Medical s.r.o; 🇨🇿 Ricany, Czech Republic

Jnana Sanjeevani Medical Centre; 🇮🇳 Bangalore, Karntaka, India

ICON Manchester CPU; 🇬🇧 Manchester, UK, United Kingdom

Maulana Azad Medical College & Associate Hospitals; 🇮🇳 New Delhi, India

MV Hospital for Diabetes (P) Ltd; 🇮🇳 Chennai, Tamil Nadu, India

Kovai Diabetes Speciality Centre and Hospital; 🇮🇳 Coimbatore, Tamil Nadu, India

Arthur Asirvathma Hospital; 🇮🇳 Madhurai, Tamil Nadu, India

Getwell Hospital and Research Centre; 🇮🇳 Nagpur, Maharastra, India

K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre; 🇮🇳 Belgaum, Karnataka, India

Jehangir Clinical development Centre Pvt Ltd; 🇮🇳 Pune, Maharashtra, India

TOTALL Diabetes Hormone Institute; 🇮🇳 Indore, Madhya Pradesh, India

NeuroHelp s.r.o; 🇨🇿 Olomouc, Prague, Czech Republic