deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT00492323

An Effectiveness and Safety Study With RWJ-333369 (Carisbamate) for the Study of Postherpetic Neuralgia (PHN).

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia.

Sponsor: SK Life Science, Inc.

Updated 9 times since 2017 Last updated: Apr 27, 2018 Started: Mar 31, 2007 Primary completion: Jun 30, 2008 Completion: Jun 30, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00492323, this PHASE2 trial focuses on Herpes Zoster and Neuralgia and remains completed. Sponsored by SK Life Science, Inc., it has been updated 9 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.

Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash (shingles), can last up to years later, and for which therapies are often limited by incomplete pain relief and side effects. This is a randomized (study medication is assigned by chance), double-blind (neither the Investigator or the patient know the name of the assigned study medication), placebo-controlled, crossover, parallel-group, multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia (PHN). The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN, as measured by average daily PHN pain scores. Patients will receive 200 mg of RWJ-333369 or matching placebo tablets, given in equally divided doses twice daily by mouth, with or without food, for 4 weeks in each of the 2 treatment periods.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotCompleted~Nov 2018 – ~Jan 2021 · 26 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotCompleted~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE2

Show 4 earlier versions
  1. Nov 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Jun 2018 — Nov 2018 [monthly]

    Completed PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Mar 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • SK Life Science, Inc.
Data source: SK Life Science, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.