Clinical trial NCT01726413: A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients).
Official title: A Phase II, 4-Week Randomised, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Peripheral Neuropathy
Keywords: Diabetic neuropathy
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
Collaborators: name: Glenmark Pharmaceuticals S.A.
First posted: 2012-11-14
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. 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. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.


Eligibility criteria: Inclusion Criteria:

1. Patients willing to provide voluntary written informed consent
2. Male and female 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

Primary outcomes:
measure: Mean 24-hour average pain intensity (API) score.
timeFrame: Week 4
Secondary outcomes:
measure: Mean night-time API Score
timeFrame: 4 weeks
measure: Patient Global Impression of Change
timeFrame: 4 weeks
measure: Clinician Global Impression of Change
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Olomouc
country: Czech Republic
facility: NeuroHelp s.r.o
state: Prague
city: Prague
country: Czech Republic
facility: DADO Medical s.r.o
city: Ricany
country: Czech Republic
facility: DADO Medical s.r.o
city: Mainz
country: Germany
facility: Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
city: Bangalore
country: India
facility: Bangalore Clinisearch
state: Karnataka
city: Belgaum
country: India
facility: K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
state: Karnataka
city: Bangalore
country: India
facility: Jnana Sanjeevani Medical Centre
state: Karntaka
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Pune
country: India
facility: Jehangir Clinical development Centre Pvt Ltd
state: Maharashtra
city: Nagpur
country: India
facility: Getwell Hospital and Research Centre
state: Maharastra
city: Chennai
country: India
facility: MV Hospital for Diabetes (P) Ltd
state: Tamil Nadu
city: Coimbatore
country: India
facility: Kovai Diabetes Speciality Centre and Hospital
state: Tamil Nadu
city: Madhurai
country: India
facility: Arthur Asirvathma Hospital
state: Tamil Nadu
city: New Delhi
country: India
facility: Maulana Azad Medical College & Associate Hospitals
city: Manchester
country: United Kingdom
facility: ICON Manchester CPU
state: UK
Study officials:
affiliation: Kovai Diabetes Speciality Centre and Hospital
name: Dr. Balamurugan Ramanathan
role: PRINCIPAL_INVESTIGATOR
affiliation: MV Hospital for Diabetes (P) Ltd
name: Dr. Vijay Viswanathan
role: PRINCIPAL_INVESTIGATOR
affiliation: K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
name: Dr. Mallikarjun V Jali
role: PRINCIPAL_INVESTIGATOR
affiliation: TOTALL Diabetes Hormone Institute
name: Dr. Sunil M Jain
role: PRINCIPAL_INVESTIGATOR
affiliation: Maulana Azad Medical College & Associate Hospitals
name: Dr. Dinesh Dhanwal
role: PRINCIPAL_INVESTIGATOR
affiliation: Jnana Sanjeevani Medical Centre
name: Dr. S Srikanta
role: PRINCIPAL_INVESTIGATOR
affiliation: Getwell Hospital and Research Centre
name: Dr. Jayashri Shembalkar
role: PRINCIPAL_INVESTIGATOR
affiliation: ICON Manchester CPU
name: Dr Peter Dewland
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
name: Dr. Prof Thomas Forst
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangalore Clinisearch
name: Dr. Paramesh Shammana
role: PRINCIPAL_INVESTIGATOR
affiliation: Arthur Asirvathma Hospital
name: Dr. Arthur Asirvatham
role: PRINCIPAL_INVESTIGATOR
affiliation: Jehangir Clinical Development Centre Pvt. Ltd.
name: Dr. Mohan Magdum
role: PRINCIPAL_INVESTIGATOR
affiliation: NeuroHelp s.r.o
name: Dr. Blanka Lubenova
role: PRINCIPAL_INVESTIGATOR
affiliation: DADO Medical s.r.o
name: Dr. David Dolezil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jain SM, Balamurugan R, Tandon M, Mozaffarian N, Gudi G, Salhi Y, Holland R, Freeman R, Baron R. Randomized, double-blind, placebo-controlled trial of ISC 17536, an oral inhibitor of transient receptor potential ankyrin 1, in patients with painful diabetic peripheral neuropathy: impact of preserved small nerve fiber function. Pain. 2022 Jun 1;163(6):e738-e747. doi: 10.1097/j.pain.0000000000002470. Epub 2021 Sep 2.