Post Operative Dental Pain Clinical Trial
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
| Verified date | October 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 328 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Investigative Site | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual Analog Scale of Pain Intensity (VASPI) reduction from baseline 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. As the primary outcome measure, the VASPI reduction from Baseline would be compared at 60 minutes between the two treatment arms. The primary efficacy objective is to show that a single dose of 50 mg diclofenac-K SGC is superior to a single dose of 400 mg ibuprofen tablets in reducing the VASPI score. | 60 minutes postdose | No |
| Secondary | Visual Analog Scale of Pain Intensity (VASPI) reduction from baseline at different time points | VASPI score reduction from baseline to 15, 30, 45, and 90 minutes, and 2, 4, 6, 7, and 8 hours post dose. | 15, 30, 45, and 90 minutes, and 2, 4, 6, 7, and 8 hours post dose | No |
| Secondary | Area under the curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) reduction from Baseline | The area under the curve (AUC) of VASPI reduction from baseline for each time point, by using the trapezoidal rule. | 1, 2, 4, 6, 7, and 8 hours postdose | No |
| Secondary | Time to onset of first perceptible pain relief (FPR) | Using the double stopwatch technique, participant starts two stopwatches at dosing, and stops the first stopwatch as soon as he/she first begins to feel 'any' relief from pain. The time elapsed is recorded as the FPR. | Within 8 hours postdose | No |
| Secondary | Time to onset of meaningful pain relief (MPR) | Using the double stopwatch technique, participant starts two stopwatches at dosing, and stops the second stopwatch as soon as he/she begins to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR. | Within 8 hours postdose | No |
| Secondary | Time to confirmed first perceptible pain relief | Time to onset of first perceptible pain relief (FPR), provided the FPR is subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant starts two stopwatches at dosing, and records FPR by stopping the first stopwatch when he/she first experiences 'any' pain relief. FPR is 'confirmed' only if the participant also stops the second stopwatch indicating 'meaningful pain relief'. | Within 8 hours postdose | No |
| Secondary | Sum of pain intensity difference (SPID) | Pain intensity difference (PID) is the difference between the Baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations would also be done at 1, 2, 4 and 6 hours post dose | 1, 2, 4, 6, and 8 hours postdose | No |
| Secondary | Total pain relief (TOTPAR) | TOTPAR: Total pain relief is the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours will be calculated. | 1, 2, 4, 6, and 8 hours postdose | No |
| Secondary | Peak analgesic effect | Highest PID and highest VASPI reduction achieved during the treatment period (dose administration to 8 hours postdose), before the use of rescue medication (in case rescue medication is used). | From dose administration to 8 hours post dose | No |
| Secondary | Peak pain relief | Highest pain relief achieved during the treatment period (between dose administration and 8 hours post dose), before the intake of rescue medication (in case rescue medication is used) | From dose administration to 8 hours post dose | No |
| Secondary | Duration of analgesia | Duration of analgesia (time to first use of rescue medication) will be evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. | From dose administration to 8 hours post dose | No |
| Secondary | Proportion of patients needing rescue medication | The proportion of patients needing rescue medication within the 8 hour treatment period will be evaluated. | From dose administration to 8 hours post dose | No |
| Secondary | Patient's global assessment of response to treatment (PGART) | PGART will be measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement would be taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period). | From dose administration to 8 hour postdose | No |
| Secondary | Safety profile as measured by Adverse Events and Serious Adverse Events | Safety profile of single dose diclofenac potassium 50 mg soft gelatin capsule and single dose ibuprofen 400 mg tablet would be studied. Adverse Events (AEs) would be recorded from ICF signatures till 'end of study' visit for each patient. Serious Adverse Events (SAEs) would be recorded from ICF signatures till 30 days after 'end of study' visit for each patient. | From Informed Consent Form signatures to 30 days post 'end of study' for a patient | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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