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Study Summary
This trial is testing the safety and how well a drug works in children after surgery.
- Postoperative Pain
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 57 Patients • NCT03323385Trial Design
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Who is running the clinical trial?
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- You have taken meloxicam, a medication, within 7 days before the surgery on Day 1.You have a bleeding disorder that could get worse if you take a certain type of medication called NSAIDs.
- Group 1: N1539
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How hazardous is the use of N1539 for affected individuals?
"The drug N1539 was given a score of 3 on our 1-3 scale as it is approved for use in Phase 4 clinical trials, thus implying that there is significant evidence backing its safety."
Who meets the requisite eligibility criteria for enrollment in this trial?
"Eligibility for this trial requires that the patient has postoperative pain and falls within the age range of 2 to 16 years old. 90 participants are desired in total."
Is the minimum age requirement for participation in this study more than 25 years of age?
"The parameters for participation in this trial stipulate that applicants must be aged two to sixteen. Furthermore, there are 69 clinical trials targeting minors and 369 specifically focusing on elderly individuals."
Is this research effort presently recruiting participants?
"The information found on clinicaltrials.gov discloses that this medical trial is actively seeking applicants, with the listing being first published on February 24th 2022 and most recently updated May 26th of the same year."
How many individuals are currently in the sample cohort of this research?
"Affirmative. Clinicaltrials.gov data shows that the trial, first registered on February 24th 2022, is actively seeking applicants. At this time, 90 individuals need to be recruited from 3 different medical facilities."
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