PainPhase 3CODINCT04972292
Fixed Dose Combination of COdeine + DIpyrone to Mitigate Moderate to Intense Pain Post-impacted Third Lower Molar Extraction
A Phase 3 study testing FDC of codeine 30 mg/dipyrone 500 mg and Tylex in people with Pain, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
Trial summary
A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil). Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Pain
- What is being tested?
- FDC of codeine 30 mg/dipyrone 500 mg and Tylex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesBrazil
- Study dates
- 8 Nov 2023to 30 May 2024
- Phase
- Phase 3
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged between 16 and 35 years old (inclusive).
- Presence of impacted third lower molar with surgical removal indicated (diagnosed via panoramic x-ray within six [6] months before inclusion in the study), at vertical, mesioangular or horizontal position as per the Winter's classification, provided that it belongs to the following Pell \& Gregory's classes:
- Maximum surgery duration of 30 minutes, counted from the initial incision to the impacted third molar extraction.
- Moderate to intense postoperative pain (≥ 40 mm at a VAS of 0-100 mm) up to four (4) hours after the end of the surgery (counted from the end of the suture).
- Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure.
Who cannot join
- Known hypersensitivity to dipyrone or to other pirazolones or pirazolidines (e.g.: phenazone, propyphenazone, isopropylaminophenazone, phenylbutazone, oxyphenbutazone), including history of previous agranulocytosis with one of these substances;
- Known hypersensitivity to codeine or to other opioid agents;
- Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;
- Bone marrow function impairment (e.g.: after cytostatic treatment) or hematopoietic system diseases;
- History of bronchospasm or other anaphylactoid reactions (e.g.: hives, rhinitis, angioedema) associated with the use of analgesics, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen;
- History of significant hypotensive reaction associated with the administration of dipyrone;
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- Abuse of illegal drugs, including alcoholism; emotional instability and/or previous attempt of suicide;
- Pregnancy or breastfeeding.
- Women of childbearing potential who do not agree to use a known effective birth control method, unless the participants are surgically sterile or state they are expressly free of the risk of getting pregnant for not having sexual intercourse or for having sexual intercourse with no reproductive potential.
- Participation in a clinical research protocol within the past 12 months, unless the investigator considers that the participation in the study could result in a direct benefit to the subject.
- Presence of any condition that, in the investigator's opinion, would make the subject ineligible to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Eurofarma Laboratórios S.A
Brasil, São Paulo, 06696-000
Eurofarma Laboratorios S.A
São Paulo, São Paulo, 06696-000
About this study
Official title: A Clinical, Multicenter, Randomized, Parallel-group, Double-blind, Double-dummy, Comparative Study of Non-inferiority of the Fixed Dose Combination of Codeine 30 mg/Dipyrone 500 mg From Eurofarma Versus Tylex® (Codeine 30 mg/Paracetamol 500 mg) in the Treatment of Moderate to Intense Pain Post-impacted Third Lower Molar Extraction
A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Read the detailed description
Subjects aged between 16 and 35 years old, with indicated surgical removal of impacted third lower molar, will be randomized at a 1:1 ratio to receive the FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA (experimental drug) or the FDC of codeine 30 mg/paracetamol 500 mg (Tylex® - Janssen-Cilag Farmacêutica Ltda) as tablets for up to three (3) days. Subjects whose surgery lasts no more than 40 minutes and showing moderate to intense postoperative pain up to four (4) hours after surgery will be randomized. The first study drug administration will take place at the clinical investigation site when the postsurgical pain becomes moderate/intense (≥ 40 mm at a visual analogue scale [VAS] of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to three (3) days (72 hours after the initial dose). Subjects will evaluate the pain relief using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in 1-hour intervals (1, 2, 3, 4, 5 and 6h). The sum of the relief scores over 6 hours determines the TOTPAR6
Subjects who meet all of the eligibility criteria will be randomized to one of the following treatment groups:
Group 1: FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA (experimental drug) - Subjects randomized to this group will receive one (1) experimental drug tablet + one (1) Tylex® placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm).
Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) - Subjects randomized to this group will receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm).
The subjects will be allowed to use the rescue medication if necessary: Paracetamol 500 mg (Tylenol® 500 mg).
All subjects must have three (3) on-site visits at the research site. Three (3) phone calls will take place between the on-site visits: Screening visit (Vs), randomization visit (Vr), first phone call (CT1), second phone call (CT2), third phone call (CT3), final visit (Vf).
The period for including subjects in the study will start after the required ethical and regulatory approvals and its estimated duration will be of up to 12 months. The approximate study duration will be of 9 ± 2 days for each subject.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
- Conditions
- Pain
- Being tested
- FDC of codeine 30 mg/dipyrone 500 mg, Tylex
- Keywords
- postoperative, third lower molar extraction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC of codeine 30 mg/dipyrone 500 mgDrug
Group 1: receive one (1) experimental drug tablet (FCD of codeine 30mg/dipyrone 500mg) + one (1) Tylex® placebo.
TylexDrug
Group 2: receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1: FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA | Experimental | Subjects randomized to this group will receive one (1) experimental drug tablet + one (1) Tylex® placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to 3 days (72 hours after the initial dose). Receives: Drug: FDC of codeine 30 mg/dipyrone 500 mg |
| Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) | Active comparator | Subjects randomized to this group will receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to 3 days (72 hours after the initial dose). Receives: Drug: Tylex |
What is being measured
The primary outcome is the main question the study is designed to answer.
sum of pain relief scores over 6 hours (TOTPAR6)
After the first study treatment dose is given, subjects will evaluate the pain relief using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in 1-hour intervals (1, 2, 3, 4, 5 and 6 hours). The sum of the relief scores over 6 hours determines the TOTPAR6, which ranges from 0 to 24, with a higher score indicating more pain relief.
Measured: 6 hours
Secondary outcomes (1)
Sum of pain relief scores over four (4) hours (TOTPAR4)
After the first study treatment dose is given, subjects will evaluate the pain relief using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in 1-hour intervals (1, 2, 3, 4 hours)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start8 Nov 2023
- Primary completion28 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972292
- Sponsor's protocol ID
- EF174
- Acronym
- CODI
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Multicenter, Randomized, Parallel-group, Double-blind, Double-dummy, Comparative Study of Non-inferiority of the Fixed Dose Combination of Codeine 30 mg/Dipyrone 500 mg From Eurofarma Versus Tylex® (Codeine 30 mg/Paracetamol 500 mg) in the Treatment of Moderate to Intense Pain Post-impacted Third Lower Molar Extraction
- ClinicalTrials.gov ID
- NCT04972292
- Acronym / sponsor ID
- CODI / EF174
- Conditions
- Pain
- Keywords
- postoperative, third lower molar extraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 22 Jul 2021 (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.
A clinical, multicenter, randomized, parallel-group, double-blind, double-dummy, comparative study of non-inferiority.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Detailed description
Subjects aged between 16 and 35 years old, with indicated surgical removal of impacted third lower molar, will be randomized at a 1:1 ratio to receive the FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA (experimental drug) or the FDC of codeine 30 mg/paracetamol 500 mg (Tylex® - Janssen-Cilag Farmacêutica Ltda) as tablets for up to three (3) days. Subjects whose surgery lasts no more than 40 minutes and showing moderate to intense postoperative pain up to four (4) hours after surgery will be randomized. The first study drug administration will take place at the clinical investigation site when the postsurgical pain becomes moderate/intense (≥ 40 mm at a visual analogue scale [VAS] of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to three (3) days (72 hours after the initial dose). Subjects will evaluate the pain relief using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in 1-hour intervals (1, 2, 3, 4, 5 and 6h). The sum of the relief scores over 6 hours determines the TOTPAR6
Subjects who meet all of the eligibility criteria will be randomized to one of the following treatment groups:
Group 1: FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA (experimental drug) - Subjects randomized to this group will receive one (1) experimental drug tablet + one (1) Tylex® placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm).
Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) - Subjects randomized to this group will receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm).
The subjects will be allowed to use the rescue medication if necessary: Paracetamol 500 mg (Tylenol® 500 mg).
All subjects must have three (3) on-site visits at the research site. Three (3) phone calls will take place between the on-site visits: Screening visit (Vs), randomization visit (Vr), first phone call (CT1), second phone call (CT2), third phone call (CT3), final visit (Vf).
The period for including subjects in the study will start after the required ethical and regulatory approvals and its estimated duration will be of up to 12 months. The approximate study duration will be of 9 ± 2 days for each subject.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA | Experimental | Drug: FDC of codeine 30 mg/dipyrone 500 mgSubjects randomized to this group will receive one (1) experimental drug tablet + one (1) Tylex® placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to 3 days (72 hours after the initial dose). |
| Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) | Active comparator | Drug: TylexSubjects randomized to this group will receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet when the postoperative pain becomes moderate to intense (≥ 40 mm at a VAS of 0-100 mm). Then, subjects will be instructed to use the study treatment whenever it is necessary for pain relief, respecting a minimal interval of six (6) hours between two administrations, for up to 3 days (72 hours after the initial dose). |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged between 16 and 35 years old (inclusive).
- Presence of impacted third lower molar with surgical removal indicated (diagnosed via panoramic x-ray within six [6] months before inclusion in the study), at vertical, mesioangular or horizontal position as per the Winter's classification, provided that it belongs to the following Pell \& Gregory's classes:
- Maximum surgery duration of 30 minutes, counted from the initial incision to the impacted third molar extraction.
- Moderate to intense postoperative pain (≥ 40 mm at a VAS of 0-100 mm) up to four (4) hours after the end of the surgery (counted from the end of the suture).
- Informed Consent Form (ICF) and Informed Assent Form (IAF) signature, when applicable, before performing any study procedure.
Key exclusion criteria (11 listed)
- Known hypersensitivity to dipyrone or to other pirazolones or pirazolidines (e.g.: phenazone, propyphenazone, isopropylaminophenazone, phenylbutazone, oxyphenbutazone), including history of previous agranulocytosis with one of these substances;
- Known hypersensitivity to codeine or to other opioid agents;
- Known hypersensitivity to paracetamol or to any component of the Tylex® formulation;
- Bone marrow function impairment (e.g.: after cytostatic treatment) or hematopoietic system diseases;
- History of bronchospasm or other anaphylactoid reactions (e.g.: hives, rhinitis, angioedema) associated with the use of analgesics, such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen;
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 |
|---|---|---|
| FDC of codeine 30 mg/dipyrone 500 mgGroup 1: receive one (1) experimental drug tablet (FCD of codeine 30mg/dipyrone 500mg) + one (1) Tylex® placebo. | Drug | Group 1: FDC of codeine 30 mg/dipyrone 500 mg from Eurofarma Laboratórios SA |
| TylexGroup 2: receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet | Drug | Group 2: Tylex® (codeine 30 mg/paracetamol 500 mg) |
Primary outcome
sum of pain relief scores over 6 hours (TOTPAR6)
Time frame: 6 hours
After the first study treatment dose is given, subjects will evaluate the pain relief using a 5-point categorical scale (0 = no relief, 1 = little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief) in 1-hour intervals (1, 2, 3, 4, 5 and 6 hours). The sum of the relief scores over 6 hours determines the TOTPAR6, which ranges from 0 to 24, with a higher score indicating more pain relief.
1 secondary outcome
Sum of pain relief scores over four (4) hours (TOTPAR4)
Time frame: 4 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 26 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FDC of codeine 30 mg/dipyrone 500 mg and Tylex in people with Pain, run by Eurofarma Laboratorios S.A. at 2 sites in Brazil.
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 5 inclusion and 11 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. 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?
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?
sum of pain relief scores over 6 hours (TOTPAR6) (time frame: 6 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 26 Oct 2026.