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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: Completed Phase 2 study, sponsored by SK Life Science.
NCT01521598 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01521598 record still lists
NCT01521598 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01521598 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01521598's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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