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

NCT06237231 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: DIT112-III-0123
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Moderate Pain; Severe Pain

Keywords

pain

Outcome Measures

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.

  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).

  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).

  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);

  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).

  24 hours

Study Arms (3)

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.

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.

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.

Drug: TRAMADOL; Drug: DIT112 Placebo; Drug: Dipyrone Placebo

Interventions

DIT112 DRUG

DIT112 tablet

DIT112

DIPYRONE DRUG

Dipyrone tablet 1.000mg

DIPYRONE

TRAMADOL DRUG

Tramadol tablet 50mg

TRAMADOL

DIT112 Placebo DRUG

DIT112 placebo tablet

DIPYRONE; TRAMADOL

Dipyrone Placebo DRUG

Dipyrone placebo tablet

DIT112; TRAMADOL

Tramadol Placebo DRUG

Tramadol placebo capsule

DIPYRONE; DIT112

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• i. 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Pain

Interventions

Dipyrone; Tramadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: February 15, 2025
• Primary Completion: March 15, 2025
• Study Completion (Estimated): April 10, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02