Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05081102
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2021-10-04
Brief Title:
Fixed-dose Combination of Oxycodone OXIcodona IbuproFEN in Pain Relief After Third Molar Extraction
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Clinical Multicenter Randomized Parallel-group Double-dummy Comparative Study of Non-inferiority of the Fixed-dose Combination of Oxycodone 5 mgIbuprofen 400 mg From Eurofarma Versus Tylex Codeine 30 mgParacetamol 500 mg in the Treatment of Moderate to Intense Pain Post-impacted Third Lower Molar Extraction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OXIFEN
Brief 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
Study will only be conducted in research centers in Brazil please do not send e-mail if your center is outside brazil
Detailed Description:
Patients aged between 16 and 35 years with indication for surgical removal of impacted lower third molar will be randomized at a 11 ratio to receive FDC oxycodone 5 mgibuprofen 400 mg from Eurofarma Laboratórios SA experimental drug or FDC codeine 30 mgparacetamol 500 mg Tylex - Janssen-Cilag Farmacêutica Ltda as tablets for up to three 03 days Participants whose surgery lasts no more than 40 minutes starting from the initial incision to the extraction of impacted third molar and who experience post-surgical pain that is moderate to intense in intensity up to four 04 hours after the surgery ends will be randomized The first administration of the study treatment will be performed at the clinical investigation site when post-surgical pain reaches moderateintense intensity 40 mm on a 0-100 mm Visual Analogue Scale VAS
Participants will be instructed to from then on use the study treatment as needed for pain relief observing a minimum interval of six 06 hours between two intakes for up to three 03 days 72 hours after the initial dose
Subjects who meet all of the eligibility criteria will be randomized to one of the following treatment groups
Group 1 FDC oxycodone 5 mgibuprofen 400 mg from Eurofarma Laboratórios SA experimental drug - Participants randomized to this group will receive one 01 tablet of the experimental drug one 01 tablet of Tylex placebo when post-surgical pain intensity reaches moderate to intense intensity 40 mm on a 0-100 mm VAS
Group 2 Tylex codeine 30 mgparacetamol 500 mg - Participants randomized to this group will receive one 01 Tylex tablet codeine 30 mgparacetamol 500 mg one 01 tablet of FCD placebo when post-surgical pain intensity reaches moderate to intense intensity 40 mm on a 0-100 mm VAS
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 enrolling participants in the study will begin after the necessary ethical and regulatory approvals and will have an estimated duration of up to 12 months
The approximate duration of the study will be 16 2 days for each participant
Study will only be conducted in research centers in Brazil please do not send e-mail if your center is outside brazil
Participants will be instructed to from then on use the study treatment as needed for pain relief observing a minimum interval of six 06 hours between two intakes for up to three 03 days 72 hours after the initial dose
Subjects who meet all of the eligibility criteria will be randomized to one of the following treatment groups
Group 1 FDC oxycodone 5 mgibuprofen 400 mg from Eurofarma Laboratórios SA experimental drug - Participants randomized to this group will receive one 01 tablet of the experimental drug one 01 tablet of Tylex placebo when post-surgical pain intensity reaches moderate to intense intensity 40 mm on a 0-100 mm VAS
Group 2 Tylex codeine 30 mgparacetamol 500 mg - Participants randomized to this group will receive one 01 Tylex tablet codeine 30 mgparacetamol 500 mg one 01 tablet of FCD placebo when post-surgical pain intensity reaches moderate to intense intensity 40 mm on a 0-100 mm VAS
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 enrolling participants in the study will begin after the necessary ethical and regulatory approvals and will have an estimated duration of up to 12 months
The approximate duration of the study will be 16 2 days for each participant
Study will only be conducted in research centers in Brazil please do not send e-mail if your center is outside brazil
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None