NCT01521598 is a Phase 2 clinical trial of SKL11197 in Painful Diabetic Neuropathy, sponsored by SK Life Science, Inc..

Who is sponsoring NCT01521598?

NCT01521598 is sponsored by SK Life Science, Inc..

What drugs are being tested in NCT01521598?

Interventions in NCT01521598: SKL11197, Placebo.

What condition does NCT01521598 study?

NCT01521598 studies Painful Diabetic Neuropathy.

Is NCT01521598 still recruiting?

NCT01521598 is currently completed. Last updated 18 May 2015.

Last reviewed 2015-05-18 · How we verify

NCT01521598

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy

Completed Phase 2 Last updated 18 May 2015

What this trial tests

Phase 2 trial testing SKL11197 in Painful Diabetic Neuropathy in 128 participants. Completed in 1 June 2013.

Timeline

1 January 2012

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	SK Life Science, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	128
Start date	1 January 2012
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	13 locations across United States

Drugs / interventions tested

SKL11197 — full drug profile →
Placebo

Conditions studied

Painful Diabetic Neuropathy — all drugs for Painful Diabetic Neuropathy →

Sponsor

SK Life Science, Inc. — full company profile →

Who can join

18 and older, any sex, with Painful Diabetic Neuropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Relief of diabetic neuropathy pain
Time frame: 24 hours

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Painful Diabetic Neuropathy

Currently open trials in the same condition.

NCT06423391 — Multimodal Intervention for Painful Diabetic Neuropathy: NeuOst Feasibility Trial · NA · active not recruiting
NCT05754190 — Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA · recruiting
NCT05777317 — Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy · NA · active not recruiting
NCT04699734 — Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy · NA · recruiting

Other SK Life Science, Inc. trials

Trials by the same sponsor.

NCT06453213 — Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy · Phase 4 · active not recruiting
NCT05572255 — A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Admini · Phase 1 · completed
NCT05388435 — Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients · Phase 1, PHASE2 · terminated
NCT04791553 — Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment · Phase 1 · completed
NCT04903314 — Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01521598 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by SK Life Science, Inc.
Last refreshed: 18 May 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01521598.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing