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).

Painful Diabetic Peripheral Neuropathy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726413
• Other study ID #: GRC 17536-203
• Secondary ID: 2012-002320-33
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2012
• Last updated: October 1, 2014
• Start date: November 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Pain
• Painful Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• GRC 17356

• Matching Placebo

Locations

Country	Name	City	State
Czech Republic	NeuroHelp s.r.o	Olomouc	Prague
Czech Republic	DADO Medical s.r.o	Prague
Czech Republic	DADO Medical s.r.o	Ricany
Germany	Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)	Mainz
India	Bangalore Clinisearch	Bangalore	Karnataka
India	Jnana Sanjeevani Medical Centre	Bangalore	Karntaka
India	K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre	Belgaum	Karnataka
India	MV Hospital for Diabetes (P) Ltd	Chennai	Tamil Nadu
India	Kovai Diabetes Speciality Centre and Hospital	Coimbatore	Tamil Nadu
India	TOTALL Diabetes Hormone Institute	Indore	Madhya Pradesh
India	Arthur Asirvathma Hospital	Madhurai	Tamil Nadu
India	Getwell Hospital and Research Centre	Nagpur	Maharastra
India	Maulana Azad Medical College & Associate Hospitals	New Delhi
India	Jehangir Clinical development Centre Pvt Ltd	Pune	Maharashtra
United Kingdom	ICON Manchester CPU	Manchester	UK

Sponsors (2)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals S.A.

Countries where clinical trial is conducted

Czech Republic,  Germany,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour average pain intensity (API) score.		Week 4	No
Secondary	Mean night-time API Score		4 weeks	No
Secondary	Patient Global Impression of Change		4 weeks	No
Secondary	Clinician Global Impression of Change		4 weeks	No