Clinical trial NCT02476422: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Dental Pain
Keywords: Diclofenac potassium
Post-operative dental pain
Moderate to severe pain
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

Key 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).

Primary outcomes:
measure: Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose
timeFrame: 60 minutes postdose
Secondary outcomes:
measure: Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points
timeFrame: 15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose
measure: Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points
timeFrame: 15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose
measure: Time to Confirmed First Perceptible Pain Relief
timeFrame: Within 8 hours postdose
measure: Time to Onset of Meaningful Pain Relief (MPR)
timeFrame: Within 8 hours postdose
measure: Time to Onset of First Perceptible Pain Relief (FPR)
timeFrame: Within 8 hours postdose
measure: Sum of Pain Intensity Difference (SPID)
timeFrame: 1, 2, 4, 6, and 8 hours postdose
measure: Summed Total Pain Relief (TOTPAR) at Different Time Points
timeFrame: 1, 2, 4, 6, and 8 hours postdose
measure: Peak Analgesic Effect
timeFrame: From dose administration to 8 hours post dose
measure: Duration of Analgesia
timeFrame: From dose administration to 8 hours post dose
measure: Number of Patients Needing Rescue Medication
timeFrame: From dose administration to 8 hours post dose
measure: Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)
timeFrame: At 8 hour postdose prior to use of rescue medication
measure: Number of Patients With Any Adverse Events, Serious Adverse Events and Death
timeFrame: time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)
Other outcomes:
Locations:
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: