Orthodontic PainPhase 3NCT05845008
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
A Phase 3 study testing Acetaminophen/Naproxen Sodium Fixed Combination in people with Orthodontic Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of a fixed combination of acetaminophen/naproxen sodium when administered as multiple doses over a period of up to 10 days in adolescents 12 to below 17 years of age with post-procedure orthodontic pain. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Acetaminophen/Naproxen Sodium Fixed Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 26 Jul 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Weigh 72 pounds or greater and have a body mass index (BMI)-for-age between the 5th and 95th percentile (inclusive) at Screening
- Have undergone an orthodontic procedure within 4 hours prior to baseline (enrollment) visit
- Females of childbearing potential and males agree to the contraceptive requirements of study
Who cannot join
- Are female and are pregnant, breastfeeding, or trying to become pregnant or male with a pregnant partner or a partner currently trying to become pregnant
- Have a positive urine drug test on screening or enrollment
- Are not able to swallow whole tablets or capsules
- Arrive at the site on the day of enrollment with motion sickness and/or have a history of frequent motion sickness (car sickness) in the past year, which in the judgement of the investigator is likely to confound assessment of adverse events
- Routinely use oral analgesics greater than or equal to (>=) 5 times per week
- Have a known allergy or hypersensitivity to naproxen (or other nonsteroidal anti-inflammatory drugs including aspirin) or acetaminophen or have asthma
Show all 10Show fewer
- Have presence or a history of major medical condition that in the Investigator's opinion may jeopardize the participant's safety or wellbeing or the integrity of the study
- Have a history of chronic use of tranquilizers, alcohol, tobacco/vaping, or substance abuse, as judged by the Investigator site staff, in the last year
- Have a history of endoscopically documented peptic ulcer disease or bleeding disorder in the last two years
- Have a diagnosis of gastroesophageal reflux disorder, or experienced frequent heartburn in the past year
Trial locations and contacts
1 site in 1 country.
United States1 site
JBR Clinical Research LLP
Salt Lake City, Utah, 84107
About this study
Official title: An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain
The purpose of this study is to evaluate the safety of a fixed combination of acetaminophen/naproxen sodium when administered as multiple doses over a period of up to 10 days in adolescents 12 to below 17 years of age with post-procedure orthodontic pain.
- Conditions
- Orthodontic Pain
- Being tested
- Acetaminophen/Naproxen Sodium Fixed Combination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen/Naproxen Sodium Fixed CombinationDrug
Acetaminophen/naproxen sodium fixed combination tablets, oral.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen/Naproxen Sodium Fixed Combination | Experimental | Participants will self-administer a fixed combination of acetaminophen/naproxen sodium orally as multiple doses over a period of up to 10 days. Receives: Drug: Acetaminophen/Naproxen Sodium Fixed Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the investigational product (IP). A TEAE is an AE that occurs after the first dose of study drug, or an AE that started before the first use of study drug and worsened after taking the study drug.
Measured: Up to Day 10
Number of Participants with Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the IP. A SAE is an AE or suspected adverse reaction resulting in any of the following outcomes: result in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly/birth defect; is considered medically significant; is a suspected transmission of any infectious agent via a medical product.
Measured: Up to Day 10
Number of Participants with Treatment-related AEs
An AE is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the IP. Treatment-related AEs are adverse events evaluated by the investigator as possible, probable or very likely related to investigational product.
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion26 Jul 2024 (estimated)
Why it stopped: The study is no longer required due to change in development program strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, Principal investigator, JBR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845008
- Sponsor's protocol ID
- CCSPAP005204
- Other IDs
- CCSPAP005204
- Status last verified
- Feb 2024
- First submitted
- 25 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain
- ClinicalTrials.gov ID
- NCT05845008
- Acronym / sponsor ID
- CCSPAP005204
- Conditions
- Orthodontic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study is no longer required due to change in development program strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 26 Jul 2024 (estimated)
- First posted
- 6 May 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 purpose of this study is to evaluate the safety of a fixed combination of acetaminophen/naproxen sodium when administered as multiple doses over a period of up to 10 days in adolescents 12 to below 17 years of age with post-procedure orthodontic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen/Naproxen Sodium Fixed Combination | Experimental | Drug: Acetaminophen/Naproxen Sodium Fixed CombinationParticipants will self-administer a fixed combination of acetaminophen/naproxen sodium orally as multiple doses over a period of up to 10 days. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Weigh 72 pounds or greater and have a body mass index (BMI)-for-age between the 5th and 95th percentile (inclusive) at Screening
- Have undergone an orthodontic procedure within 4 hours prior to baseline (enrollment) visit
- Females of childbearing potential and males agree to the contraceptive requirements of study
Key exclusion criteria (10 listed)
- Are female and are pregnant, breastfeeding, or trying to become pregnant or male with a pregnant partner or a partner currently trying to become pregnant
- Have a positive urine drug test on screening or enrollment
- Are not able to swallow whole tablets or capsules
- Arrive at the site on the day of enrollment with motion sickness and/or have a history of frequent motion sickness (car sickness) in the past year, which in the judgement of the investigator is likely to confound assessment of adverse events
- Routinely use oral analgesics greater than or equal to (>=) 5 times per week
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 |
|---|---|---|
| Acetaminophen/Naproxen Sodium Fixed CombinationAcetaminophen/naproxen sodium fixed combination tablets, oral. | Drug | Acetaminophen/Naproxen Sodium Fixed Combination |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 10
An adverse event (AE) is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the investigational product (IP). A TEAE is an AE that occurs after the first dose of study drug, or an AE that started before the first use of study drug and worsened after taking the study drug.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 10
An AE is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the IP. A SAE is an AE or suspected adverse reaction resulting in any of the following outcomes: result in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly/birth defect; is considered medically significant; is a suspected transmission of any infectious agent via a medical product.
Number of Participants with Treatment-related AEs
Time frame: Up to Day 10
An AE is any untoward medical occurrence that occurs in a participant after he/she has signed an informed consent for a study. The event does not need to have a suspected causal relationship with the IP. Treatment-related AEs are adverse events evaluated by the investigator as possible, probable or very likely related to investigational product.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Related trials for Orthodontic Pain
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
Not yet recruiting
Effect of Alpha Binaural Beat Music on Pain After Orthodontic Separator Placement
Orthodontic Pain (D013850), Anxiety
Recruiting
Comparison Between the Effectiveness of Low-Grade Laser Therapy vs. Conventional Analgesics for Pain Reduction During Orthodontic Treatment in Malay Female Population
Orthodontic Pain
Active, not recruiting
Effects of PBM on Fixed-appliance Orthodontic Patients
Orthodontics, Root Resorption
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.
Todd Bertoch principal investigator
JBR Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen/Naproxen Sodium Fixed Combination in people with Orthodontic Pain, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 5 Mar 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Day 10). The study lists 3 primary outcomes in all. 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 5 Mar 2024.