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A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521598
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
SK Life Science, Inc.

Tracking Information
First Submitted Date  ICMJE January 26, 2012
First Posted Date  ICMJE January 30, 2012
Last Update Posted Date June 11, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
Relief of diabetic neuropathy pain [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01521598 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
Average daily pain score [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
Official Title  ICMJE A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy
Brief 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.

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;

  1. a pre-study medication washout/screening phase upto 3 weeks
  2. a 3-week, open label phase
  3. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Neuropathy
Intervention  ICMJE
  • Drug: SKL11197
    SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.
  • Drug: Placebo
    This is the placebo. Patients will be randomized the placebo.
Study Arms  ICMJE
  • Experimental: SKL11197
    This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
    Intervention: Drug: SKL11197
  • Placebo Comparator: Placebo
    This arm is the placebo comparator arm. Patients will be randomized to this arm.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2013)
128
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2012)
120
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years or older
  2. Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
  3. At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
  4. HbA1c < 12 % at Screening
  5. Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
  6. Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
  7. 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,
  8. 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.

Exclusion Criteria:

  1. Pregnant or lactating females
  2. Subjects with BMI over 40
  3. Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
  4. Subjects with known clinically significant decreased blood flow to the extremities
  5. Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
  6. Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
  7. Have profound autonomic dysfunction, or brittle diabetes;
  8. Evidence of amputations (including toes), open ulcers, or Charcot joint.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01521598
Other Study ID Numbers  ICMJE SKL11197C006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SK Life Science, Inc.
Study Sponsor  ICMJE SK Life Science, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marc Kamin, M.D. SKLSI (Sponsor)
PRS Account SK Life Science, Inc.
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP