Painful Diabetic Peripheral NeuropathyPhase 2NCT01726413
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).
A Phase 2 study testing GRC 17356 in people with Painful Diabetic Peripheral Neuropathy, run by Glenmark Pharmaceuticals Ltd. India at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- What is being tested?
- GRC 17356
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 15 sitesin 4 countries
- Study dates
- Nov 2012to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing to provide voluntary written informed consent
- Male and female 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
India10 sites
Bangalore Clinisearch
Bangalore, Karnataka, 560043
Jnana Sanjeevani Medical Centre
Bangalore, Karntaka, 560078
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Belagavi, Karnataka, 590010
MV Hospital for Diabetes (P) Ltd
Chennai, Tamil Nadu, 600 013
Kovai Diabetes Speciality Centre and Hospital
Coimbatore, Tamil Nadu, 641 009
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
Arthur Asirvathma Hospital
Madurai, Tamil Nadu, 625020
Getwell Hospital and Research Centre
Nagpur, Maharashtra, 440012
Maulana Azad Medical College & Associate Hospitals
New Delhi, New Delhi, 110002
Jehangir Clinical development Centre Pvt Ltd
Pune, Maharashtra, 411001
Czechia3 sites
NeuroHelp s.r.o
Olomouc, Prague, 772 00
DADO Medical s.r.o
Prague, Prague, 12000
DADO Medical s.r.o
Říčany, Ricany
Germany1 site
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Mainz, Germany, 55116
About this study
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.
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.
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Being tested
- GRC 17356, Matching Placebo
- Keywords
- Diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRC 17356Drug
Matching PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Test Arm | Experimental | GRC17356 for daily administration Receives: Drug: GRC 17356 |
| Placebo | Placebo comparator | Matching placebo for daily administration Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24-hour average pain intensity (API) score.
Measured: Week 4
Secondary outcomes (3)
Mean night-time API Score
Measured: 4 weeks
Patient Global Impression of Change
Measured: 4 weeks
Clinician Global Impression of Change
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Dr. Balamurugan Ramanathan, Principal investigator, Kovai Diabetes Speciality Centre and HospitalDr. Vijay Viswanathan, Principal investigator, MV Hospital for Diabetes (P) LtdDr. Mallikarjun V Jali, Principal investigator, K.L.E.S Dr. Prabhakar Kore Hospital & Medical research CentreDr. Sunil M Jain, Principal investigator, TOTALL Diabetes Hormone InstituteDr. Dinesh Dhanwal, Principal investigator, Maulana Azad Medical College & Associate HospitalsDr. S Srikanta, Principal investigator, Jnana Sanjeevani Medical CentreDr. Jayashri Shembalkar, Principal investigator, Getwell Hospital and Research CentreDr Peter Dewland, Principal investigator, ICON Manchester CPU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726413
- Sponsor's protocol ID
- GRC 17536-203
- Other IDs
- 2012-002320-33
- Status last verified
- Oct 2014
- First submitted
- 9 Nov 2012
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34490850
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01726413
- Acronym / sponsor ID
- GRC 17536-203
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Keywords
- Diabetic neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Arm | Experimental | Drug: GRC 17356GRC17356 for daily administration |
| Placebo | Placebo comparator | Drug: Matching PlaceboMatching placebo for daily administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients willing to provide voluntary written informed consent
- Male and female 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRC 17356 | Drug | Test Arm |
| Matching Placebo | Drug | Placebo |
Primary outcome
Mean 24-hour average pain intensity (API) score.
Time frame: Week 4
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Derived from this study: PubMed 34490850Jain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Balamurugan Ramanathan principal investigator
Kovai Diabetes Speciality Centre and Hospital
Dr. Vijay Viswanathan principal investigator
MV Hospital for Diabetes (P) Ltd
Dr. Mallikarjun V Jali principal investigator
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRC 17356 in people with Painful Diabetic Peripheral Neuropathy, run by Glenmark Pharmaceuticals Ltd. India at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India, Czechia, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 24-hour average pain intensity (API) score. (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.