Postoperative PainPhase 2NCT00986882
To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients
A Phase 2 study testing SAF312A and Ibuprofen in people with Postoperative Pain, run by Novartis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SAF312A and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Postoperative Pain
- Being tested
- SAF312A, Placebo, Ibuprofen
- Keywords
- Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAF312ADrug
PlaceboDrug
IbuprofenDrug
| Study group | Role | What they receive |
|---|---|---|
| SAF312A (2 doses in part B; 5 - 6 doses in part C) | Experimental | Not described Receives: Drug: SAF312A |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
Measured: 24 hours
Secondary outcomes (2)
To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain
Measured: 24 hours
To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986882
- Sponsor's protocol ID
- CSAF312A2103
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00986882
- Acronym / sponsor ID
- CSAF312A2103
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAF312A (2 doses in part B; 5 - 6 doses in part C) | Experimental | Drug: SAF312A |
| Placebo | Placebo comparator | Drug: Placebo |
| Ibuprofen | Active comparator | Drug: Ibuprofen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAF312A | Drug | SAF312A (2 doses in part B; 5 - 6 doses in part C) |
| Placebo | Drug | Placebo |
| Ibuprofen | Drug | Ibuprofen |
Primary outcome
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
2 secondary outcomes
To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain
Time frame: 24 hours
To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 36729473Mangwani-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.
- Results for CSAF312A2103 from the Novartis Clinical Trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAF312A and Ibuprofen in people with Postoperative Pain, run by Novartis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00986882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.