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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT01521598
First received: January 26, 2012
Last updated: July 17, 2013
Last verified: July 2013

January 26, 2012
July 17, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
Relief of diabetic neuropathy pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01521598 on ClinicalTrials.gov Archive Site
Average daily pain score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Painful Diabetic Neuropathy
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01521598
SKL11197C006
No
SK Life Science
SK Life Science
Not Provided
Study Director: Marc Kamin, M.D. SKLSI (Sponsor)
SK Life Science
July 2013

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