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)

This study has been withdrawn prior to enrollment.
(Due to new scientific evidence assessment, the study design was revised before the study started recruitment)
Sponsor:
Collaborator:
Glenmark Pharmaceuticals SA
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier:
NCT01556152
First received: March 15, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Painful Diabetic Neuropathy
Drug: GRC 17536 (Medium Dose)
Drug: GRC 17536 (Low Dose)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Glenmark Pharmaceuticals Ltd. India:

Primary Outcome Measures:
  • Mean 24-hour average pain intensity (API) score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean night-time API Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Clinician Global Impression of Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse events (AE) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556152

Locations
Germany
Site 2
Mainz, Germany
United Kingdom
Site 1
Manchester, United Kingdom
Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals SA
Investigators
Study Director: Dr. Kavita Muchandi, MD Glenmark Pharmaceuticals Ltd
  More Information

No publications provided

Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT01556152     History of Changes
Other Study ID Numbers: GRC 17536-201, 2011-005879-16
Study First Received: March 15, 2012
Last Updated: November 9, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014