Moderate PainPhase 3ALIVNCT06237231
Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars
A Phase 3 study testing DIT112, DIPYRONE and TRAMADOL in people with Moderate Pain and Severe Pain, run by EMS.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of DIT112 in adolescents and adults with acute pain after dental surgery for the extraction of impacted third molars. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Moderate Pain, Severe Pain
- What is being tested?
- DIT112, DIPYRONE and TRAMADOL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 10 Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the Free and Informed Consent Form (TCLE) and/or the Free and Informed Assent Form (TALE) in two copies;
- Age equal to or over 15 years old;
- Indication of extraction of two (02) impacted third molars, one (01) lower third molar and one (01) upper molar on the same side;
- Third molar with bone impactions observed through panoramic radiography, with classification by Winter (1926) (1) mesioangular or vertical, and classification according to Pell \& Gregory (1933) (2):
- Class II position B; or ii. Class III position A or B
- Presence of pain of moderate or severe intensity (score greater than or equal to 5 when assessed using an 11-point numeric pain scale) within up to four (04) hours after the end of the surgery.
Who cannot join
- Presence of local conditions (lesions in the region of the third molars) that may interfere with the extraction of third molars, such as, but not limited to, pericoronitis, periodontitis, tumors, cysts and inflammation and/or infection in the region to be operated;
- Presence of any clinical observation finding (clinical/physical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
- Presence of a known gastroduodenal ulcer or diagnosis of persistent gastritis;
- Presence of compromised bone marrow function or diseases of the hematopoietic system;
- Presence of known severe renal and/or hepatic insufficiency;
- Diagnosis of epilepsy not adequately controlled;
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- Diagnosis of acute intermittent hepatic porphyria;
- Presence of known congenital glucose-6-phosphatedehydrogenase deficiency;
- History of allergy or intolerance to tramadol, diclofenac and pyrazolones (e.g. phenazone, propyphenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone) including, for example, previous experience of agranulocytosis with one of these substances;
- Use of sedative, hypnotic or psychotropic medications in the last 24 hours before surgery;
- Use of anticoagulant medications in the last seven (07) days before surgery;
- Current chronic treatment with opioids or corticosteroids;
- Current treatment with selective cyclooxygenase - 2 (COX2) inhibitors;
- Use of monoamine oxidase inhibitors (MAOIs) such as, but not limited to, phenelzine, tranylcypromine and isocarboxazid, in the last 14 days prior to the day of surgery;
- Use of any analgesic and/or anti-inflammatory medication in the three (03) days prior to the day of surgery;
- Known allergy or hypersensitivity to the components of the medicines used during the clinical trial;
- Surgery to extract third molars lasting more than 60 minutes, considering from the beginning of the incision until the end of the extraction;
- Technical failure in anesthesia or need to administer more than three tubes of anesthetic for each molar;
- Presence of temporomandibular joint dysfunction or limited mouth opening;
- Occurrence of a surgical accident resulting from the extraction of impacted third molars which, in the opinion of the investigator, could interfere with the procedures or evaluations of the trial, such as, but not limited to, intraoperative hemorrhage, probable injury to the inferior alveolar nerve, board fracture bone and soft tissue laceration;
- Current medical history of cancer and/or cancer treatment in the last 5 years;
- History of alcohol and/or illicit drug abuse disorder in the last two (02) years;
- Participants who are pregnant, breastfeeding or planning to become pregnant, or female participants of childbearing potential who are not using a reliable method of contraception;
- Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be a direct benefit to the participant.
About this study
Official title: Phase III, Multicenter, Double-blind, Triple-dummy, Randomized, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars
The purpose of this study is to evaluate the efficacy and safety of DIT112 in adolescents and adults with acute pain after dental surgery for the extraction of impacted third molars.
- Conditions
- Moderate Pain, Severe Pain
- Being tested
- DIT112, DIPYRONE, TRAMADOL, DIT112 Placebo, Dipyrone Placebo
- Keywords
- pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIT112Drug
DIT112 tablet
DIPYRONEDrug
Dipyrone tablet 1.000mg
TRAMADOLDrug
Tramadol tablet 50mg
DIT112 PlaceboDrug
DIT112 placebo tablet
Dipyrone PlaceboDrug
Dipyrone placebo tablet
Tramadol PlaceboDrug
Tramadol placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| DIT112 | Experimental | The study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet DIT112, oral;
1 capsule tramadol placebo, oral;
1 tablet dipyrone placebo, oral. Receives: Drug: DIT112; Drug: Dipyrone Placebo; Drug: Tramadol Placebo |
| DIPYRONE | Active comparator | The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 tablet dipyrone, oral;
1 tablet DIT112 placebo, oral;
1 capsule tramadol placebo, oral. Receives: Drug: DIPYRONE; Drug: DIT112 Placebo; Drug: Tramadol Placebo |
| TRAMADOL | Active comparator | The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows:
1 capsule tramadol, oral;
1 tablet dipyrone placebo, oral;
1 tablet DIT112 placebo, oral. Receives: Drug: TRAMADOL; Drug: DIT112 Placebo; Drug: Dipyrone Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain relief within four (04) hours after the first PSI administration, assessed using the area under the curve of pain interruption scores (TOTPAR0-4h).
(TOTPAR4), with pain relief assessed using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) at times 0.5, 1, 2, 3 and 4 hours.
Measured: 0-4 hours
Secondary outcomes (4)
Total pain relief within six (06) hours after the first PSI administration, assessed using the area under the curve of pain interruption scores (TOTPAR0-6h).
(TOTPAR6), with pain relief assessed using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) at times 0.5, 1, 2, 3,4, 5 and 6 hours.
Measured: 0-6 hours
Pain intensity in periods of four (04) and six (06) hours after the first PSI administration, assessed through the difference in pain intensity score (SPID0-4h and SPID0-6h, respectively).
pain intensity four (04) hours and six (06) hours after administration of the first dose of the PSI (SPID0-4 and SPID0-6h, respectively) using an 11-point numerical scale (0 to 10 points, with 0 = absence of pain and 10 = worst possible pain) in times 0, 0.5, 1, 2, 3, 4, 5 and 6 hours.
Measured: 0-4 hours and 0-6 hours, respectively
Use of the rescue medication (time for the first use of the rescue medication within the first 24 hours after the first PSI administration);
medication accounting
Measured: 24 hours
Overall effectiveness of the treatment according to the participant 24 hours after the first administration of the PSI (distribution of participants according to a 5-point categorical scale).
Global assessment of the treatment by the participant 24 hours after administration of the first dose of PSI, using a 5-point categorical scale (0 = much worse, 1 = worse, 2 = the same, 3 = better, 4 = much better).
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 posted1 Feb 2024
- Study start15 Feb 2025 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate PainStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237231
- Sponsor's protocol ID
- DIT112-III-0123
- Acronym
- ALIV
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Double-blind, Triple-dummy, Randomized, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars
- ClinicalTrials.gov ID
- NCT06237231
- Acronym / sponsor ID
- ALIV / DIT112-III-0123
- Conditions
- Moderate Pain, Severe Pain
- Keywords
- pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- 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 purpose of this study is to evaluate the efficacy and safety of DIT112 in adolescents and adults with acute pain after dental surgery for the extraction of impacted third molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIT112 | Experimental | Drug: DIT112, Drug: Dipyrone Placebo, Drug: Tramadol PlaceboThe study is triple-dummy. The patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet DIT112, oral; 1 capsule tramadol placebo, oral; 1 tablet dipyrone placebo, oral. |
| DIPYRONE | Active comparator | Drug: DIPYRONE, Drug: DIT112 Placebo, Drug: Tramadol PlaceboThe patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 tablet dipyrone, oral; 1 tablet DIT112 placebo, oral; 1 capsule tramadol placebo, oral. |
| TRAMADOL | Active comparator | Drug: TRAMADOL, Drug: DIT112 Placebo, Drug: Dipyrone PlaceboThe patient must take 3 pills, with a minimum interval of 6/6 hours for 3 days, if pain, as follows: 1 capsule tramadol, oral; 1 tablet dipyrone placebo, oral; 1 tablet DIT112 placebo, oral. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the Free and Informed Consent Form (TCLE) and/or the Free and Informed Assent Form (TALE) in two copies;
- Age equal to or over 15 years old;
- Indication of extraction of two (02) impacted third molars, one (01) lower third molar and one (01) upper molar on the same side;
- Third molar with bone impactions observed through panoramic radiography, with classification by Winter (1926) (1) mesioangular or vertical, and classification according to Pell \& Gregory (1933) (2):
- Presence of pain of moderate or severe intensity (score greater than or equal to 5 when assessed using an 11-point numeric pain scale) within up to four (04) hours after the end of the surgery.
Key exclusion criteria (24 listed)
- Presence of local conditions (lesions in the region of the third molars) that may interfere with the extraction of third molars, such as, but not limited to, pericoronitis, periodontitis, tumors, cysts and inflammation and/or infection in the region to be operated;
- Presence of any clinical observation finding (clinical/physical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
- Presence of a known gastroduodenal ulcer or diagnosis of persistent gastritis;
- Presence of compromised bone marrow function or diseases of the hematopoietic system;
- Presence of known severe renal and/or hepatic insufficiency;
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 |
|---|---|---|
| DIT112DIT112 tablet | Drug | DIT112 |
| DIPYRONEDipyrone tablet 1.000mg | Drug | DIPYRONE |
| TRAMADOLTramadol tablet 50mg | Drug | TRAMADOL |
| DIT112 PlaceboDIT112 placebo tablet | Drug | DIPYRONE, TRAMADOL |
| Dipyrone PlaceboDipyrone placebo tablet | Drug | DIT112, TRAMADOL |
| Tramadol PlaceboTramadol placebo capsule | Drug | DIPYRONE, DIT112 |
Primary outcome
Total pain relief within four (04) hours after the first PSI administration, assessed using the area under the curve of pain interruption scores (TOTPAR0-4h).
Time frame: 0-4 hours
(TOTPAR4), with pain relief assessed using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) at times 0.5, 1, 2, 3 and 4 hours.
4 secondary outcomes
Total pain relief within six (06) hours after the first PSI administration, assessed using the area under the curve of pain interruption scores (TOTPAR0-6h).
Time frame: 0-6 hours
Pain intensity in periods of four (04) and six (06) hours after the first PSI administration, assessed through the difference in pain intensity score (SPID0-4h and SPID0-6h, respectively).
Time frame: 0-4 hours and 0-6 hours, respectively
Use of the rescue medication (time for the first use of the rescue medication within the first 24 hours after the first PSI administration);
Time frame: 24 hours
Overall effectiveness of the treatment according to the participant 24 hours after the first administration of the PSI (distribution of participants according to a 5-point categorical scale).
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DIT112, DIPYRONE and TRAMADOL in people with Moderate Pain and Severe Pain, run by EMS.
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 6 inclusion and 24 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: opening soon, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Total pain relief within four (04) hours after the first PSI administration, assessed using the area under the curve of pain interruption scores (TOTPAR0-4h). (time frame: 0-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.