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



Status:Completed
Conditions:Post-Surgical Pain, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Musculoskeletal
Healthy:No
Age Range:18 - 45
Updated:4/28/2016
Start Date:September 2009
End Date:March 2011

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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

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.


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
We found this trial at
1
site
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
?
mi
from
Salt Lake City, UT
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