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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986882
• Other study ID #: CSAF312A2103
• Status: Completed
• Phase: Phase 2
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• SAF312A

• Placebo

• Ibuprofen

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain		24 hours
Secondary	To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain		24 hours
Secondary	To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication		24 hours

External Links

•   Results for CSAF312A2103 from the Novartis Clinical Trials website