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NCT00794430 · ClinicalTrials.gov registry record · Phase 2

Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain

A Phase 2 study, sponsored by Vernalis (R&D).

Completed
Registry status
Phase 2
Development phase
161
Enrollment target

NCT00794430 is a Phase 2 study that has completed, run by Vernalis (R&D). The registered enrollment target is 161 participants.

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The verdict

NCT00794430, a Phase 2 study, has completed, sponsored by Vernalis (R&D).

COMPLETED
Registry status
Phase 2
Development phase
161 participants
Enrollment target

Study Summary

Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13 week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid increments every one or two weeks, starting from 100 mg bid. A 2 week follow-up period will conclude patient participation in the study.

Interventions

  • DRUG Placebo
  • DRUG V3381

Trial Details

FieldValue
Enrollment Target 161 participants
Start Date 2008-12
Est. Completion 2009-12
Phase Phase 2

Sponsor

Vernalis (R&D)

4 total trials

What the Registry Record Tells You About NCT00794430

The ClinicalTrials.gov registry entry for NCT00794430 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vernalis (R&D), which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00794430 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00794430 about?

NCT00794430 is a clinical study titled "Study of the Safety, Tolerability and Efficacy of V3381 in Patients With Diabetic Peripheral Neuropathic Pain". Randomised, double-blind, placebo-controlled, parallel group, multicentre study of oral doses of V3381, titrated to effect. A 2-week single-blind run-in period will be followed by a 13 week double-blind titration and maintenance phase. Doses will be titrated up in 100 mg bid increments every one or ...

What is the current status of trial NCT00794430?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2008-12. Estimated completion is 2009-12.

What interventions are being tested in trial NCT00794430?

The interventions under investigation include: Placebo (DRUG), V3381 (DRUG).

Who is sponsoring clinical trial NCT00794430?

This trial is sponsored by Vernalis (R&D), which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.