A Double-blind, Randomized, Single Dose, Placebo Controlled, Three Part Study to Evaluate the Safety and Tolerability, Efficacy and Dose Response of SAF312 in Postoperative Dental Pain Patients

Novartis1 site in 1 country183 target enrollmentSeptember 2009

ConditionsPostoperative Pain

InterventionsSAF312A Placebo Ibuprofen

DrugsSAF312A Placebo Ibuprofen

Overview

Phase: Phase 2
Intervention: SAF312A
Conditions: Postoperative Pain
Sponsor: Novartis
Enrollment: 183
Locations: 1
Primary Endpoint: To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study will assess the analgesic efficacy and safety and tolerability of a single oral dose of SAF312 in postoperative dental pain patients after 3rd molar extraction.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

March 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Extraction of two or more impacted (partial or full) third molars. At least one of the impaction should be lower jaw.
•Each patient will evaluate her/his post-surgical pain intensity prior to taking trial medication.
•To be eligible for this trial, post surgical pain must be moderate to severe -- Subjects should be in good health otherwise as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
•Female subjects should be either postmenopausal or should have had surgical sterilization.

Exclusion Criteria

•Patients with known hypersensitivity to diclofenac, aspirin, acetaminophen or to antipyretics or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following treatment with aspirin or other agents with cyclooxygenase-inhibiting activity such as NSAIDs.
•Use of antipyretic/analgesic drugs from 48 hrs pre-dose to 24 hrs postdose
•Presence of bleeding disorder (history of excessive bleeding after dental procedures or minor injuries)
•Patients with Diabetes mellitus.
•Presence, history of, or family history of malignant hyperthermia or anesthesia-related events that may be suggestive of malignant hyperthermia.
•An abnormal ECG at screening, including PR\>200 ms, QRS\>110 ms, QTcF\<380 or \>450 ms, lead II T wave abnormalities. Non-specific T wave abnormalities in leads other than lead II are permissible if not accompanied by any other morphological abnormalities.
•Patients with infection e.g. dental abscess
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

SAF312A (2 doses in part B; 5 - 6 doses in part C)

Intervention: SAF312A

Placebo

Intervention: Placebo

Ibuprofen

Intervention: Ibuprofen

Outcomes

Primary Outcomes

To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain

Time Frame: 24 hours

Secondary Outcomes

To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain(24 hours)
To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication(24 hours)