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

NCT02476422 | Completed Phase 3 Results

• 1 other identifier: CCAT458M2402
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Operative Dental Pain

Keywords

Diclofenac potassium; Post-operative dental pain; Moderate to severe pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose

  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.

  60 minutes postdose

Secondary Outcomes (12)

• Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points

  15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose

• Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points

  15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose

• Time to Confirmed First Perceptible Pain Relief

  Within 8 hours postdose

• Time to Onset of Meaningful Pain Relief (MPR)

  Within 8 hours postdose

• Time to Onset of First Perceptible Pain Relief (FPR)

  Within 8 hours postdose

Study Arms (2)

Dilcofenac potassium + placebo to Ibuprofen

EXPERIMENTAL

Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.

Drug: Diclofenac potassium; Drug: Placebo to ibuprofen

Ibuprofen + placebo to diclofenac potassium

ACTIVE COMPARATOR

Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.

Drug: Ibuprofen; Drug: Placebo to diclofenac potassium

Interventions

Diclofenac potassium DRUG

Single dose of diclofenac 50 mg soft gelatin capsule

Also known as: diclofenac-K

Dilcofenac potassium + placebo to Ibuprofen

Ibuprofen DRUG

Single dose of ibuprofen 400 mg tablet

Also known as: Ibuprofen acid

Ibuprofen + placebo to diclofenac potassium

Placebo to ibuprofen DRUG

Single dose of placebo to ibuprofen 400 mg tablet

Also known as: Placebo

Dilcofenac potassium + placebo to Ibuprofen

Placebo to diclofenac potassium DRUG

Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule

Also known as: Placebo

Ibuprofen + placebo to diclofenac potassium

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level.
• Patients having a moderate to severe Baseline pain intensity as assessed by a score of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic dissipation.

You may not qualify if:

• Patients who require the removal of a single third molar, or 2 ipsilateral third molars where mandibular molar is not fully or partially impacted.
• Patients with active peptic ulcer disease or a history of significant gastrointestinal disease or any gastrointestinal bleeding.
• Patients with coagulation or bleeding disorders.
• Patients with a positive drug or alcohol screen.
• Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic, muscle relaxant, or tranquilizer within 5 elimination half-lives before administration of study drug (other than surgical anesthetic prior to and during dental surgery).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Diclofenac; Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenylpropionates

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: June 19, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08

Locations

US (1)