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Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars

ConditionsModerate PainSevere Pain
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15+
SponsorEMS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • DIT112

    Drug

    DIT112 tablet

  • DIPYRONE

    Drug

    Dipyrone tablet 1.000mg

  • TRAMADOL

    Drug

    Tramadol tablet 50mg

  • DIT112 Placebo

    Drug

    DIT112 placebo tablet

  • Dipyrone Placebo

    Drug

    Dipyrone placebo tablet

  • Tramadol Placebo

    Drug

    Tramadol placebo capsule

Treatment groups

252 Participants
are divided into 3 treatment groups
Group A: DIT112Experimental treatment 3 interventions
Group B: DIPYRONEActive comparator 3 interventions
Group C: TRAMADOLActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
0-4 hours

Secondary outcomes

1

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.

Time frame
0-6 hours
2

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.

Time frame
0-4 hours and 0-6 hours, respectively
3

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

Time frame
24 hours
4

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).

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: