A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy
Public ClinicalTrials.gov record NCT01521598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01521598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2011
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
- Last update posted
- Jun 10, 2015
2012 – 2013
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurology Clinic, P.C. | Northport | Alabama | 35476 | — |
| Principals Research Group | Hot Springs | Arkansas | 71901 | — |
| Clinical Trials, Inc. | Little Rock | Arkansas | 72205 | — |
| Collaborative Neuroscience Network, Inc. | Long Beach | California | 90806 | — |
| Neurological Research Institute | Santa Monica | California | 90404 | — |
| Renstar Medical Research | Ocala | Florida | 33471 | — |
| Comprehensive Clinical Development | St. Petersburg | Florida | 33716 | — |
| Clinical Research of West Florida, Inc. | Tampa | Florida | 33603 | — |
| International Clinical Research Institute | Leawood | Kansas | 66211 | — |
| Michigan Head Pain & Neurological Institute. | Ann Arbor | Michigan | 48104 | — |
| Creighton Diabetes Center | Omaha | Nebraska | 68131 | — |
| Sunstone Medical Research, LLC | Medford | Oregon | 97504 | — |
| Nerve and Muscle Center of Texas | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01521598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2015 · Synced Sep 16, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01521598 live on ClinicalTrials.gov.