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NCT02476422 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
328
Enrollment target

NCT02476422: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT02476422 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 328 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02476422, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
328 participants
Enrollment target

Study Summary

The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.

Primary Outcome

VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.

Interventions

  • DRUG Ibuprofen
  • DRUG Diclofenac potassium
  • DRUG Placebo to ibuprofen
  • DRUG Placebo to diclofenac potassium

Trial Details

FieldValue
Enrollment Target 328 participants
Start Date 2015-04
Est. Completion 2015-08
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT02476422 record still lists

NCT02476422 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 4 interventions - of which Ibuprofen is the first listed.

NCT02476422 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02476422 about?

NCT02476422 is a clinical study titled "A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain". The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.

What is the current status of trial NCT02476422?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2015-04. Estimated completion is 2015-08.

What interventions are being tested in trial NCT02476422?

The interventions under investigation include: Ibuprofen (DRUG), Diclofenac potassium (DRUG), Placebo to ibuprofen (DRUG), Placebo to diclofenac potassium (DRUG).

Who is sponsoring clinical trial NCT02476422?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02476422's enrollment target sits among peer trials

328 1074th of 2000 higher than 926 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02476422, the US trial registry maintained by the National Library of Medicine. NCT02476422 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.