Diabetic Peripheral Neuropathic PainPhase 4NCT02156336
Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)
A Phase 4 study testing Ranolazine in people with Diabetic Peripheral Neuropathic Pain, run by Horizons International Peripheral Group at 3 sites in United States.
Trial summary
The purpose of this trial is to determine if patients suffering from diabetic peripheral neuropathic pain treated with ranolazine will have a greater reduction in pain compared to placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to 8 Feb 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A minimum of 18 years of age;
- Provided signed Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) authorization for this study approved by the Institutional Review Board;
- Patients must have diabetic peripheral neuropathic pain rated at an average level of six (6) or above as documented in daily diary prior to baseline visit and noted at Baseline Visit;
- Diabetic on a stable insulin regimen or oral medication regimen as determined by the investigator [It is recommended Hba1c < 9.5%, making a note that lab normal values may vary among sites.];
- Clinical Exam Results:
- 5.07 Semmes-Weinstein Monofilament Test Subject does not sense monofilament or evokes an abnormal response in a minimum of two (2) out of five (5) test locations on the plantar surface of the foot.
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- Pin Prick Test Subject experiences allodynia, hyperalgesia, or sensory loss in two (2) out of five (5) test locations in the plantar surface - four (4) and dorsum - one (1) of the foot.
- Willing and able to comply with the requirements of the protocol and follow directions from the clinic and research staff;
- For female patients only:
- Be post-menopausal (no menses for at least 2 years) or sterilized,
- If subject of childbearing potential, not breastfeeding, has a negative pregnancy test at Baseline (pre-randomization, Day 0), has no intention of becoming pregnant during the course of the study, and is using one or more of the following contraceptive measures:
- Stable regimen of hormonal contraception
- Intra-uterine device
- Condoms with spermicide
- Diaphragm with spermicide
Who cannot join
- History of allergy or intolerance to ranolazine;
- Any condition or concomitant medication that would preclude the safe use of ranolazine as outlined in the prescribing information sheet;
- In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug;
- In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition);
- Use participation in another experimental or investigational drug or device trial;
- Pregnant or breast feeding;
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- Cirrhosis of the liver;
- Psychological or addictive disorders (not limited to, but including for example, drug and/or alcohol dependency) that may preclude patient consent or compliance, or that may confound study interpretation;
- Taking a moderate or strong CYP3A inhibitor (e.g. diltiazem, verapamil, ketoconazole, itraconazole, clarithromycin, erythromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir);
- Taking inducers of Cytochrome P450, family 3, subfamily A (CYP3A) (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort);
- Renal impairment as defined by a calculated serum creatinine clearance of < 30ml/min;
- Lower back disorders where symptoms present similarly to DPNP;
- Family history of long QT syndrome;
- Congenital long QT syndrome;
- Subjects taking tricyclic antidepressants;
- Subjects taking anti-psychotic drugs;
- Patient is taking > 850mg metformin BID;
- Any subjects currently taking pregabalin;
- Any subjects currently taking gabapentin;
- Any subject currently taking Metanx®;
- Any subjects currently taking continuous long-term narcotics;
- Grapefruit and grapefruit containing products;
- Use of P-gp inhibitors - cyclosporine.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cardiology Associates
Fairhope, Alabama, 36532
Cardiovascular Institute of the South
Houma, Louisiana, 70361
Cardiovascular Institute of the South
Lafayette, Louisiana, 70503
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Parallel Assignment, U.S. Study of Ranolazine for the Treatment of Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
The purpose of this trial is to determine if patients suffering from diabetic peripheral neuropathic pain treated with ranolazine will have a greater reduction in pain compared to placebo.
Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical animal model of neuropathic pain, the investigators hypothesize that subjects randomized to ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- Ranolazine, Placebo
- Keywords
- Diabetic Peripheral Neuropathic Pain, Ranexa, Ranolazine, Neurology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
Oral administration, BID; for a maximum of 51 days.
PlaceboDrug
Also called Sugar Pill
Oral administration, BID; for a maximum of 51 days.
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | * 500 mg PLACEBO PO 2 times a day for 1 week (Week 1)
* 1000 mg PLACEBO PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6) Receives: Drug: Placebo |
| RANOLAZINE | Active comparator | * 500 mg RANOLAZINE PO 2 times a day for 1 week (Week 1)
* 1000 mg RANOLAZINE PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6) Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo.
Measured: 6 weeks (42 Days)
Secondary outcomes (7)
Change in Quality of Life Assessment as measured by SF-36 v2
Measured: Randomization (Day 0) and Day 42
Change in pain assessment measured by the Visual Analog Scale
Measured: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Change in pain assessment measured by Short-Form McGill Pain Questionnaire
Measured: Randomization (Day 0) and Day 42
Change in pain of patients with arterial ischemia measured by Short-Form McGill Pain Questionnaire
Pain reduction of ranolazine versus placebo in subjects with diabetic peripheral neuropathic pain (DPNP) and arterial ischemia compared to those with DPNP without arterial ischemia.
Measured: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Additional pain medication
Additional pain medication after the baseline visit as needed for pain reduction in addition to the study drug.
Measured: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Occurrence of Adverse Events after randomization
The rates and severity of Adverse Events (AEs) from Randomization (Day 0) through Termination (Day 56)
Measured: 56 Days
Occurrence of Serious Adverse Events after randomization
A serious adverse event (SAE), also may be called a serious adverse drug reaction, is any untoward medical occurrence that at any dose:
- results in death,
- is life-threatening,
- requires inpatient hospitalization or prolongation of existing hospitalization,
- results in persistent or significant disability/incapacity, or
- is a congenital anomaly/birth defect.
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Why it stopped: Not enough patients met study criteria for enrollment.
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 Diabetic Peripheral Neuropathic PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizons International Peripheral Group
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Craig M Walker, MD FACC, Principal investigator, Cardiovascular Institute of the South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156336
- Sponsor's protocol ID
- HIPG-CLIN-2014-01
- Status last verified
- Feb 2017
- First submitted
- 28 May 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gould HJ 3rd, Garrett C, Donahue RR, Paul D, Diamond I, Taylor BK. Ranolazine attenuates behavioral signs of neuropathic pain. Behav Pharmacol. 2009 Dec;20(8):755-8. doi: 10.1097/FBP.0b013e3283323c90.
PubMed 19773645
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Parallel Assignment, U.S. Study of Ranolazine for the Treatment of Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
- ClinicalTrials.gov ID
- NCT02156336
- Acronym / sponsor ID
- HIPG-CLIN-2014-01
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Keywords
- Diabetic Peripheral Neuropathic Pain, Ranexa, Ranolazine, Neurology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients met study criteria for enrollment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Horizons International Peripheral GroupUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- May 2014
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 5 Jun 2014 (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.
The purpose of this trial is to determine if patients suffering from diabetic peripheral neuropathic pain treated with ranolazine will have a greater reduction in pain compared to placebo.
Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical animal model of neuropathic pain, the investigators hypothesize that subjects randomized to ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: Placebo* 500 mg PLACEBO PO 2 times a day for 1 week (Week 1) * 1000 mg PLACEBO PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6) |
| RANOLAZINE | Active comparator | Drug: Ranolazine* 500 mg RANOLAZINE PO 2 times a day for 1 week (Week 1) * 1000 mg RANOLAZINE PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- A minimum of 18 years of age;
- Provided signed Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) authorization for this study approved by the Institutional Review Board;
- Patients must have diabetic peripheral neuropathic pain rated at an average level of six (6) or above as documented in daily diary prior to baseline visit and noted at Baseline Visit;
- Diabetic on a stable insulin regimen or oral medication regimen as determined by the investigator [It is recommended Hba1c < 9.5%, making a note that lab normal values may vary among sites.];
- Clinical Exam Results:
Key exclusion criteria (23 listed)
- History of allergy or intolerance to ranolazine;
- Any condition or concomitant medication that would preclude the safe use of ranolazine as outlined in the prescribing information sheet;
- In the judgment of the investigator, any clinically-significant ongoing medical condition that might jeopardize the patient's safety or interfere with the absorption, distribution, metabolism or excretion of the study drug;
- In the judgment of the investigator, clinically-significant abnormal physical findings during screening (excluding the patient's peripheral neuropathy condition);
- Use participation in another experimental or investigational drug or device trial;
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 |
|---|---|---|
| RanolazineAlso: RanexaOral administration, BID; for a maximum of 51 days. | Drug | RANOLAZINE |
| PlaceboAlso: Sugar PillOral administration, BID; for a maximum of 51 days. | Drug | PLACEBO |
Primary outcome
Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo.
Time frame: 6 weeks (42 Days)
7 secondary outcomes
Change in Quality of Life Assessment as measured by SF-36 v2
Time frame: Randomization (Day 0) and Day 42
Change in pain assessment measured by the Visual Analog Scale
Time frame: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Change in pain assessment measured by Short-Form McGill Pain Questionnaire
Time frame: Randomization (Day 0) and Day 42
Change in pain of patients with arterial ischemia measured by Short-Form McGill Pain Questionnaire
Time frame: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Additional pain medication
Time frame: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Occurrence of Adverse Events after randomization
Time frame: 56 Days
Occurrence of Serious Adverse Events after randomization
Time frame: 56 Days
Results and safety
The study was stopped early (reason given: Not enough patients met study criteria for enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Background: PubMed 19773645Gould HJ 3rd, Garrett C, Donahue RR, Paul D, Diamond I, Taylor BK. Ranolazine attenuates behavioral signs of neuropathic pain. Behav Pharmacol. 2009 Dec;20(8):755-8. doi: 10.1097/FBP.0b013e3283323c90.
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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.
Craig M Walker, MD FACC principal investigator
Cardiovascular Institute of the South
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine in people with Diabetic Peripheral Neuropathic Pain, run by Horizons International Peripheral Group at 3 sites in United States.
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 15 inclusion and 23 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: stopped early, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Not enough patients met study criteria for enrollment.). Results are not available in the source record.
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?
Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo. (time frame: 6 weeks (42 Days)). 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 NCT02156336, 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 10 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.