To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Ibuprofen; Drug: Placebo; Drug: SAF312A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986882

CSAF312A2103

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 3 patient groups, including a placebo group

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

Experimental group

Treatment:

Drug: SAF312A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Ibuprofen

Active Comparator group

Treatment:

Drug: Ibuprofen