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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01556152
First Posted: March 16, 2012
Last Update Posted: November 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India
  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
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

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 ]

Secondary Outcome Measures:
  • Mean night-time API Score [ Time Frame: 4 weeks ]
  • Patient Global Impression of Change [ Time Frame: 4 weeks ]
  • Clinician Global Impression of Change [ Time Frame: 4 weeks ]
  • Adverse events (AE) [ Time Frame: 4 weeks ]
  • Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24 [ Time Frame: 4 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556152


Locations
Germany
Site 2
Mainz, Germany
United Kingdom
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
  More Information

Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT01556152     History of Changes
Other Study ID Numbers: GRC 17536-201
2011-005879-16 ( EudraCT Number )
First Submitted: March 15, 2012
First Posted: March 16, 2012
Last Update Posted: November 12, 2012
Last Verified: November 2012

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