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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗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.
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