Painful Diabetic NeuropathyPhase 2NCT01556152
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)
A Phase 2 study testing GRC 17536 (Medium Dose) and GRC 17536 (Low Dose) in people with Painful Diabetic Neuropathy, run by Glenmark Pharmaceuticals Ltd. India at 2 sites in 2 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 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 Neuropathy
- What is being tested?
- GRC 17536 (Medium Dose) and GRC 17536 (Low Dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Start not givento not given
- 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 (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.
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
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- GRC 17536 (Medium Dose), GRC 17536 (Low Dose), Placebo
- 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 17536 (Medium Dose)Drug
1 BD for 28 days
GRC 17536 (Low Dose)Drug
1 BD for 28 Days
PlaceboDrug
Matching Placebo for 28 Days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Active comparator | Not described Receives: Drug: GRC 17536 (Medium Dose) |
| Traetment Arm 2 | Active comparator | Not described Receives: Drug: GRC 17536 (Low Dose) |
| Treatment Arm 3 | Placebo comparator | Not described Receives: Drug: 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: 4 weeks
Secondary outcomes (5)
Mean night-time API Score
Measured: 4 weeks
Patient Global Impression of Change
Measured: 4 weeks
Clinician Global Impression of Change
Measured: 4 weeks
Adverse events (AE)
Measured: 4 weeks
Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24
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 posted16 Mar 2012 (estimated)
Why it stopped: Due to new scientific evidence assessment, the study design was revised before the study started recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic 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
- 0 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. Kavita Muchandi, MD, Study director, Glenmark Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556152
- Sponsor's protocol ID
- GRC 17536-201
- Other IDs
- 2011-005879-16
- Status last verified
- Nov 2012
- First submitted
- 15 Mar 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01556152
- Acronym / sponsor ID
- GRC 17536-201
- Conditions
- Painful Diabetic Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to new scientific evidence assessment, the study design was revised before the study started recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- First posted
- 16 Mar 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
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 (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.
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 17536 (Medium Dose)1 BD for 28 days | Drug | Treatment Arm 1 |
| GRC 17536 (Low Dose)1 BD for 28 Days | Drug | Traetment Arm 2 |
| PlaceboMatching Placebo for 28 Days | Drug | Treatment Arm 3 |
Primary outcome
Mean 24-hour average pain intensity (API) score
Time frame: 4 weeks
5 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
Adverse events (AE)
Time frame: 4 weeks
Pharmacokinetics: Cmax, Tmax, AUC 0-tau, AUC0-24
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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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. Kavita Muchandi, MD study director
Glenmark Pharmaceuticals Ltd
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRC 17536 (Medium Dose) and GRC 17536 (Low Dose) in people with Painful Diabetic Neuropathy, run by Glenmark Pharmaceuticals Ltd. India at 2 sites in 2 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: withdrawn, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 was withdrawn before enrolling participants, so there are no results.
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: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2012.