Back to resultsTo Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SAF312A
Placebo
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain
Eligibility Criteria
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
Sites / Locations
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
SAF312A (2 doses in part B; 5 - 6 doses in part C)
Placebo
Ibuprofen
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
Secondary Outcome Measures
To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain
To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00986882
Brief Title
To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAF312A (2 doses in part B; 5 - 6 doses in part C)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Ibuprofen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SAF312A
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Primary Outcome Measure Information:
Title
To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain
Time Frame
24 hours
Title
To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6323
Description
Results for CSAF312A2103 from the Novartis Clinical Trials website
Learn more about this trial
To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
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