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)

• Sponsor: Glenmark Pharmaceuticals Ltd. India (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01556152
• Collaborator: Glenmark Pharmaceuticals S.A. (Industry)
• Enrollment: 0
• Locations: 2
• Arms: 3
• Patients Per Site: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Painful Diabetic Neuropathy	Drug: GRC 17536 (Medium Dose); Drug: GRC 17536 (Low Dose); Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Arm 1	Drug: GRC 17536 (Medium Dose); 1 BD for 28 days
Active Comparator: Traetment Arm 2	Drug: GRC 17536 (Low Dose); 1 BD for 28 Days
Placebo Comparator: Treatment Arm 3	Drug: Placebo; Matching Placebo for 28 Days

Outcome Measures

Primary Outcome Measures

1. Mean 24-hour average pain intensity (API) score [4 weeks]

Secondary Outcome Measures

1. Mean night-time API Score [4 weeks]

2. Patient Global Impression of Change [4 weeks]

3. Clinician Global Impression of Change [4 weeks]

4. Adverse events (AE) [4 weeks]

5. Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24 [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site 2	Mainz		Germany
2	Site 1	Manchester		United Kingdom

Sponsors and Collaborators

• Glenmark Pharmaceuticals Ltd. India
• Glenmark Pharmaceuticals S.A.

Investigators

• Study Director: Dr. Kavita Muchandi, MD, Glenmark Pharmaceuticals Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glenmark Pharmaceuticals Ltd. India
• ClinicalTrials.gov Identifier: NCT01556152
• Other Study ID Numbers: GRC 17536-201; 2011-005879-16
• First Posted: Mar 16, 2012
• Last Update Posted: Nov 12, 2012
• Last Verified: Nov 1, 2012

• Additional relevant MeSH terms: Diabetic Neuropathies; Pain

Study Results

No Results Posted as of Nov 12, 2012