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NCT01521598 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by SK Life Science.

Completed
Registry status
Phase 2
Development phase
128
Enrollment target

NCT01521598 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 128 participants.

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The verdict

NCT01521598, a Phase 2 study, has completed, sponsored by SK Life Science.

COMPLETED
Registry status
Phase 2
Development phase
128 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG SKL11197

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2012-01
Est. Completion 2013-06
Phase Phase 2

Sponsor

SK Life Science

25 total trials

What the Registry Record Tells You About NCT01521598

The ClinicalTrials.gov registry entry for NCT01521598 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01521598 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01521598 about?

NCT01521598 is a clinical study titled "A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study 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 ...

What is the current status of trial NCT01521598?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2012-01. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01521598?

The interventions under investigation include: Placebo (DRUG), SKL11197 (DRUG).

Who is sponsoring clinical trial NCT01521598?

This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.