Acute PainPhase 2NCT05995912
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
A Phase 2 study testing etoricoxib-tramadol, Naproxen and Tramadol in people with Acute Pain and Postoperative Pain, run by Laboratorios Liomont at 1 site in Mexico.
Trial summary
The goal of the present phase IIb clinical trial was to compare the safety and efficacy of the fixed-dose combination etoricoxib-tramadol 120mg/100mg tablet (once a day, for three days) versus naproxen 220mg tablet plus tramadol 50 mg capsule in patients with acute postoperative pain after impacted third molar… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acute Pain, Postoperative Pain
- What is being tested?
- etoricoxib-tramadol, Naproxen and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteMexico
- Study dates
- 29 Sep 2021to 14 Oct 2022
- Phase
- Phase 2
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes aged from 18 to 40 years.
- Patients who agreed to participate in the study by signing the informed consent.
- Patients with indication for surgical extraction of impacted lower third molars according to the Pell and Gregory classification.
- Healthy subjects or with history of controlled chronic non-communicable diseases or that can be controlled prior to surgery, which, in the investigator's opinion, do not represent an additional risk for the patient.
- Patients who, at the investigator's discretion, meet personal and family conditions that allow them to properly comply with the activities described in the protocol and adherence to treatment.
Who cannot join
- Findings in the clinical history, vital signs, physical examination or laboratory studies suggesting abnormal conditions which represent a risk for subject's health at the investigator´s discretion.
- Hypersensitivity to any of the active ingredients and/or excipients of the investigational drugs.
- Patients with active peptic or gastroduodenal ulcer or diagnosis 30 days prior to signing the informed consent.
- Patients with history of allergic asthma reactions.
- Patients with severe hepatic dysfunction, classified as Child Pugh C or when being less, the investigator considers it an additional risk for patients.
- Patients with a creatinine clearance <30 mL/min.
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- Patients with coagulation disorders.
- Patients with Systemic Lupus Erythematosus.
- Patients with congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease who have recently (3 months) undergone coronary artery bypass grafting or angioplasty procedures.
- Patients at high risk of acute cardiovascular events (intense smoking, hypertension or uncontrolled diabetes mellitus).
- Patients with a history of systemic neoplastic diseases or under treatment with chemotherapy.
- Patients with a history of illicit drug abuse or addiction to alcohol or tobacco.
- Patients with monoamine oxidase inhibitors (MAOIs) treatment or during the last 2 weeks prior to the study drug administration.
- Patients with opioid analgesics, neuromodulators, or long-acting NSAIDs therapy who, according to medical criteria, cannot carry out a withdrawal scheme for at least five half-lives prior to surgery.
- Patients with history of seizures or who are under treatment with medications that reduce the seizure threshold and who, according to medical criteria, cannot carry out a withdrawal scheme within 30 days prior to surgery.
- Positive pregnancy test or lactating women.
- Positive rapid urine drug test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Etoricoxib-tramadol 120mg/100mg on Acute Pain After Impacted Lower Third Molar Extraction: A Double Blind Randomized Controlled Trial
The goal of the present phase IIb clinical trial was to compare the safety and efficacy of the fixed-dose combination etoricoxib-tramadol 120mg/100mg tablet (once a day, for three days) versus naproxen 220mg tablet plus tramadol 50 mg capsule in patients with acute postoperative pain after impacted third molar extraction. The main research question was: Is the analgesic efficacy of etoricoxib-tramadol 120mg/100mg tablet non-inferior to naproxen 220 mg tablet + tramadol 50 mg capsule in a clinical model of moderate to severe acute pain? After informed consent, patients were randomly assigned to one of the two arms: test product (etoricoxib-tramadol 120mg/100mg tablet) or active comparator (naproxen 220mg tablet + tramadol 50 mg capsule). After surgery, patients were requested to start the treatment with study drugs (test product was administered once daily for three days; meanwhile reference drug was administered twice a day for three days).
Investigators compared the effects of both treatments on pain intensity at different time frames using the visual analogue scale. Furthermore, the safety of investigational drugs was assessed during the study.
- Conditions
- Acute Pain, Postoperative Pain
- Being tested
- etoricoxib-tramadol, Naproxen, Tramadol
- Keywords
- Etoricoxib-tramadol, Third molar extraction, Analgesia
- Medical subject headings
- Acute Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxib-tramadolDrug
Oral administration (with or without food)
NaproxenDrug
Oral administration (with or without food)
TramadolDrug
Oral administration (with or without food)
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib-Tramadol | Experimental | Etoricoxib-Tramadol 120mg/100mg tablet, once-daily, for 3 days Receives: Drug: etoricoxib-tramadol |
| Naproxen + Tramadol | Active comparator | Naproxen 220 mg tablet + Tramadol 50 mg capsule, twice a day, for 3 days. Receives: Drug: Naproxen; Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity difference (PID)
The difference in pain intensity at 4 h after drug administration versus time 0 (baseline, before dosing)
Measured: At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)
Secondary outcomes (4)
Pain intensity difference (PID)
The difference in pain intensity at 1, 2, 3, 6, 12, 24, 48, and 72 hours after drug administration versus time 0 (baseline, before dosing)
Measured: At 1, 2, 3, 6, 12, 24, 48, and 72 hours postdosing respecto the baseline (Day 0, before dosing)
Total pain relief (TOTPAR)
TOTPAR is a time-weighted measure of AUC or total area under the pain relief curve and is a summary measure that integrates serial assessments of a subject's pain over the duration of the study or in any time frime.
Measured: At 4, 6, 12, 24, 48, 72 hours postdosing respect to the baseline (Day 0, before dosing)
Trismus control
Measurement the difference of mouth opening (in mm) at baseline (before dosing) and at the end of the study (Day 7).
Measured: At the end of the study (Day 7) respect to the baseline (Day 0, before dosing)
Adverse events
Characteristics and frequency of adverse events
Measured: From informed consent (Day -28) to the end of the study (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start29 Sep 2021
- Primary completion18 Aug 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Liomont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Infinite Clinical Research, S.A. de C.V.
- Responsible party
- Sponsor
- Investigators
- Tania A. Sibaja Ponce, M.D., Principal investigator, Oaxaca Site Management Organization, S.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995912
- Sponsor's protocol ID
- LT-04-20
- Other IDs
- LT-04-20
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2023
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Etoricoxib-tramadol 120mg/100mg on Acute Pain After Impacted Lower Third Molar Extraction: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05995912
- Acronym / sponsor ID
- LT-04-20
- Conditions
- Acute Pain, Postoperative Pain
- Keywords
- Etoricoxib-tramadol, Third molar extraction, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Laboratorios LiomontIndustry (pharma, biotech, devices)
- Collaborators
- Infinite Clinical Research, S.A. de C.V.
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 16 Aug 2023 (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 goal of the present phase IIb clinical trial was to compare the safety and efficacy of the fixed-dose combination etoricoxib-tramadol 120mg/100mg tablet (once a day, for three days) versus naproxen 220mg tablet plus tramadol 50 mg capsule in patients with acute postoperative pain after impacted third molar extraction. The main research question was: Is the analgesic efficacy of etoricoxib-tramadol 120mg/100mg tablet non-inferior to naproxen 220 mg tablet + tramadol 50 mg capsule in a clinical model of moderate to severe acute pain? After informed consent, patients were randomly assigned to one of the two arms: test product (etoricoxib-tramadol 120mg/100mg tablet) or active comparator (naproxen 220mg tablet + tramadol 50 mg capsule). After surgery, patients were requested to start the treatment with study drugs (test product was administered once daily for three days; meanwhile reference drug was administered twice a day for three days).
Investigators compared the effects of both treatments on pain intensity at different time frames using the visual analogue scale. Furthermore, the safety of investigational drugs was assessed during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib-Tramadol | Experimental | Drug: etoricoxib-tramadolEtoricoxib-Tramadol 120mg/100mg tablet, once-daily, for 3 days |
| Naproxen + Tramadol | Active comparator | Drug: Naproxen, Drug: TramadolNaproxen 220 mg tablet + Tramadol 50 mg capsule, twice a day, for 3 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both sexes aged from 18 to 40 years.
- Patients who agreed to participate in the study by signing the informed consent.
- Patients with indication for surgical extraction of impacted lower third molars according to the Pell and Gregory classification.
- Healthy subjects or with history of controlled chronic non-communicable diseases or that can be controlled prior to surgery, which, in the investigator's opinion, do not represent an additional risk for the patient.
- Patients who, at the investigator's discretion, meet personal and family conditions that allow them to properly comply with the activities described in the protocol and adherence to treatment.
Key exclusion criteria (17 listed)
- Findings in the clinical history, vital signs, physical examination or laboratory studies suggesting abnormal conditions which represent a risk for subject's health at the investigator´s discretion.
- Hypersensitivity to any of the active ingredients and/or excipients of the investigational drugs.
- Patients with active peptic or gastroduodenal ulcer or diagnosis 30 days prior to signing the informed consent.
- Patients with history of allergic asthma reactions.
- Patients with severe hepatic dysfunction, classified as Child Pugh C or when being less, the investigator considers it an additional risk for patients.
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 |
|---|---|---|
| etoricoxib-tramadolOral administration (with or without food) | Drug | Etoricoxib-Tramadol |
| NaproxenOral administration (with or without food) | Drug | Naproxen + Tramadol |
| TramadolOral administration (with or without food) | Drug | Naproxen + Tramadol |
Primary outcome
Pain intensity difference (PID)
Time frame: At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)
The difference in pain intensity at 4 h after drug administration versus time 0 (baseline, before dosing)
4 secondary outcomes
Pain intensity difference (PID)
Time frame: At 1, 2, 3, 6, 12, 24, 48, and 72 hours postdosing respecto the baseline (Day 0, before dosing)
Total pain relief (TOTPAR)
Time frame: At 4, 6, 12, 24, 48, 72 hours postdosing respect to the baseline (Day 0, before dosing)
Trismus control
Time frame: At the end of the study (Day 7) respect to the baseline (Day 0, before dosing)
Adverse events
Time frame: From informed consent (Day -28) to the end of the study (Day 7)
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 10 Oct 2024.
- 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.
Tania A. Sibaja Ponce, M.D. principal investigator
Oaxaca Site Management Organization, S.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing etoricoxib-tramadol, Naproxen and Tramadol in people with Acute Pain and Postoperative Pain, run by Laboratorios Liomont at 1 site in Mexico.
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 17 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 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain intensity difference (PID) (time frame: At 4 h (Day 0, postdosing) respect the baseline (Day 0, before dosing)). 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 10 Oct 2024.