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)

NCT01556152 | Withdrawn Phase 2 DMC

• 2 other identifiers: GRC 17536-2012011-005879-16
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

Painful Diabetic Neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean 24-hour average pain intensity (API) score

  4 weeks

Secondary Outcomes (5)

• Mean night-time API Score

  4 weeks

• Patient Global Impression of Change

  4 weeks

• Clinician Global Impression of Change

  4 weeks

• Adverse events (AE)

  4 weeks

• Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24

  4 weeks

Study Arms (3)

Treatment Arm 1

ACTIVE COMPARATOR

Drug: GRC 17536 (Medium Dose)

Traetment Arm 2

ACTIVE COMPARATOR

Drug: GRC 17536 (Low Dose)

Treatment Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GRC 17536 (Medium Dose) DRUG

1 BD for 28 days

Treatment Arm 1

GRC 17536 (Low Dose) DRUG

1 BD for 28 Days

Traetment Arm 2

Placebo DRUG

Matching Placebo for 28 Days

Treatment Arm 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain
• Other causes of neuropathy or lower extremity pain
• Complex regional pain syndrome or trigeminal neuralgia
• Lower extremity amputations other than toes
• 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
• Major depression.
• 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.
• 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

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (2)

Site 2

Mainz, Germany

Location

Site 1

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Dr. Kavita Muchandi, MD

  Glenmark Pharmaceuticals Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 16, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

GB (1); DE (1)