Painful Diabetic NeuropathyPhase 2NCT01521598
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
A Phase 2 study testing SKL11197 in people with Painful Diabetic Neuropathy, run by SK Life Science, Inc. at 13 sites in United States.
Trial summary
Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN). Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- SKL11197
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2012to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
- HbA1c < 12 % at Screening
- Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
- Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
- Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,
- If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.
Who cannot join
- Pregnant or lactating females
- Subjects with BMI over 40
- Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
- Subjects with known clinically significant decreased blood flow to the extremities
- Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
- Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
- Have profound autonomic dysfunction, or brittle diabetes;
- Evidence of amputations (including toes), open ulcers, or Charcot joint.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Michigan Head Pain & Neurological Institute.
Ann Arbor, Michigan, 48104
Principals Research Group
Hot Springs, Arkansas, 71901
Nerve and Muscle Center of Texas
Houston, Texas, 77030
International Clinical Research Institute
Leawood, Kansas, 66211
Clinical Trials, Inc.
Little Rock, Arkansas, 72205
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806
Sunstone Medical Research, LLC
Medford, Oregon, 97504
Neurology Clinic, P.C.
Northport, Alabama, 35476
Renstar Medical Research
Ocala, Florida, 33471
Creighton Diabetes Center
Omaha, Nebraska, 68131
Neurological Research Institute
Santa Monica, California, 90404
Comprehensive Clinical Development
St. Petersburg, Florida, 33716
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy
Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN).
Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy.
Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.
Read the detailed description
This study is a double-blind, placebo controlled study with three phases;
- a pre-study medication washout/screening phase upto 3 weeks
- a 3-week, open label phase
- a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.
Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- SKL11197, Placebo
- Keywords
- Diabetic Peripheral 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.
SKL11197Drug
SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.
PlaceboDrug
This is the placebo. Patients will be randomized the placebo.
| Study group | Role | What they receive |
|---|---|---|
| SKL11197 | Experimental | This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm. Receives: Drug: SKL11197 |
| Placebo | Placebo comparator | This arm is the placebo comparator arm. Patients will be randomized to this arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of diabetic neuropathy pain
Measured: 24 hours
Secondary outcomes (1)
Average daily pain score
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Kamin, M.D., Study director, SKLSI (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521598
- Sponsor's protocol ID
- SKL11197C006
- Status last verified
- May 2015
- First submitted
- 26 Jan 2012
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01521598
- Acronym / sponsor ID
- SKL11197C006
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Diabetic Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Jan 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.
Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN).
Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy.
Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.
Detailed description
This study is a double-blind, placebo controlled study with three phases;
- a pre-study medication washout/screening phase upto 3 weeks
- a 3-week, open label phase
- a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.
Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.
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 |
|---|---|---|
| SKL11197 | Experimental | Drug: SKL11197This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm. |
| Placebo | Placebo comparator | Drug: PlaceboThis arm is the placebo comparator arm. Patients will be randomized to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older
- Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
- HbA1c < 12 % at Screening
- Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
Key exclusion criteria (8 listed)
- Pregnant or lactating females
- Subjects with BMI over 40
- Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
- Subjects with known clinically significant decreased blood flow to the extremities
- Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
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 |
|---|---|---|
| SKL11197SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day. | Drug | SKL11197 |
| PlaceboThis is the placebo. Patients will be randomized the placebo. | Drug | Placebo |
Primary outcome
Relief of diabetic neuropathy pain
Time frame: 24 hours
1 secondary outcome
Average daily pain score
Time frame: 24 hours
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 11 Jun 2015.
Related trials for Painful Diabetic Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Recruiting
Comparative Study of Combination Treatment of Bionerv E+ Versus Vitamin B Complex in Treatment of Diabetic Polyneuropathy in Type 2 Diabetic Patients and Its Effect on Wound Healing
Diabetic Foot Ulcer (DFU), Diabetic Symmetrical Polyneuropathy
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.
Marc Kamin, M.D. study director
SKLSI (Sponsor)
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKL11197 in people with Painful Diabetic Neuropathy, run by SK Life Science, Inc. at 13 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 8 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 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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?
Relief of diabetic neuropathy pain (time frame: 24 hours). 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 11 Jun 2015.