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NCT00501202
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of RWJ 333369 for the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy.
Phase 2 trial testing placebo in Diabetic Neuropathy, Painful in 132 participants. Completed in 1 May 2008.
1 May 2008
Quick facts
| Lead sponsor | SK Life Science, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 1 March 2007 |
| Primary completion | 1 May 2008 |
| Estimated completion | 1 May 2008 |
Drugs / interventions tested
- placebo
- RWJ-333369 (carisbamate) — full drug profile →
Conditions studied
- Diabetic Neuropathy, Painful — all drugs for Diabetic Neuropathy, Painful →
- Diabetic Neuralgia — all drugs for Diabetic Neuralgia →
- Diabetic Polyneuropathy — all drugs for Diabetic Polyneuropathy →
- Diabetic Mononeuropathy — all drugs for Diabetic Mononeuropathy →
Sponsor
SK Life Science, Inc. — full company profile →
Who can join
Adults 18 to 75, any sex, with Diabetic Neuropathy, Painful or Diabetic Neuralgia. 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.
-
The mean of the last 7 average daily DPN scores of the first treatment period on days when study drug is taken.
Time frame: 4 weeks
Sponsor's own description
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of 200 mg of RWJ-333369 given twice daily by mouth compared with placebo in the treatment of Diabetic Peripheral Neuropathy (DPN).
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:
- PubMed search for NCT00501202
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Neuropathy, Painful
Currently open trials in the same condition.
- NCT05623111 — Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities · Phase 2 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT00501202 (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: 27 April 2018
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/NCT00501202.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing