To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
NCT ID: NCT00986882
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2009-09-30
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SAF312A (2 doses in part B; 5 - 6 doses in part C)
SAF312A
Placebo
Placebo
Ibuprofen
Ibuprofen
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SAF312A
Placebo
Ibuprofen
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jean Brown Research
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CSAF312A2103 from the Novartis Clinical Trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CSAF312A2103
Identifier Type: -
Identifier Source: org_study_id