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

NCT00794430 is a Phase 2 study that has completed, run by Vernalis (R&D). The registered enrollment target is 161 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Vernalis (R&D)

4 total trials

What the finished NCT00794430 record still lists

NCT00794430 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% higher).

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

NCT00794430 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00794430's enrollment target sits among peer trials

161 422nd of 2000 higher than 1,579 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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Source: ClinicalTrials.gov NCT00794430, the US trial registry maintained by the National Library of Medicine. NCT00794430 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.