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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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Dental Pain

Intervention: Diclofenac potassium (Drug); Ibuprofen (Drug); Placebo to ibuprofen (Drug); Placebo to diclofenac potassium (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
William L Buchanan, M.D., D.D.S., Principal Investigator, Affiliation: University of Texas Health Science Center, San Antonio, Texas

Overall contact:
Novartis Pharmaceuticals, Phone: 1-888-669-6682

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.

Clinical Details

Official title: A Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Tolerability of 50 mg Diclofenac Potassium Soft Gelatin Capsules Compared With 400 mg Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Visual Analog Scale of Pain Intensity (VASPI) reduction from baseline at 60 minutes post dose

Secondary outcome:

Visual Analog Scale of Pain Intensity (VASPI) reduction from baseline at different time points

Area under the curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) reduction from Baseline

Time to onset of first perceptible pain relief (FPR)

Time to onset of meaningful pain relief (MPR)

Time to confirmed first perceptible pain relief

Sum of pain intensity difference (SPID)

Total pain relief (TOTPAR)

Peak analgesic effect

Peak pain relief

Duration of analgesia

Proportion of patients needing rescue medication

Patient's global assessment of response to treatment (PGART)

Safety profile as measured by Adverse Events and Serious Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. Exclusion Criteria:

- 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). Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Pharmaceuticals, Phone: 1-888-669-6682

Novartis Investigative Site, Austin, Texas 78744, United States; Recruiting
Additional Information

Starting date: April 2015
Last updated: June 16, 2015

Page last updated: August 23, 2015

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