To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
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
1 other identifier
interventional
183
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 postoperative-pain
Started Sep 2009
Typical duration for phase_2 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedDecember 19, 2020
September 1, 2020
1.5 years
September 29, 2009
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
24 hours
Secondary Outcomes (2)
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
Study Arms (3)
SAF312A (2 doses in part B; 5 - 6 doses in part C)
EXPERIMENTALPlacebo
PLACEBO COMPARATORIbuprofen
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PMID: 36729473DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 19, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share