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)

Painful Diabetic Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01556152
• Other study ID #: GRC 17536-201
• Secondary ID: 2011-005879-16
• Status: Withdrawn
• Phase: Phase 2
• First received: March 15, 2012
• Last updated: November 9, 2012

Study information

• Verified date: November 2012
• 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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 (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

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 Neuropathy

Intervention

Drug:
• GRC 17536 (Medium Dose)
1 BD for 28 days
• GRC 17536 (Low Dose)
1 BD for 28 Days
• Placebo
Matching Placebo for 28 Days

Locations

Country	Name	City	State
Germany	Site 2	Mainz
United Kingdom	Site 1	Manchester

Sponsors (2)

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

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour average pain intensity (API) score		4 weeks	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
Secondary	Adverse events (AE)		4 weeks	Yes
Secondary	Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24		4 weeks	No