Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447040
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2020-06-23
Brief Title:
AcetaminophenNaproxen Sodium Dose Ranging Study
Sponsor:
Johnson Johnson Consumer Inc McNeil Consumer Healthcare Division
Organization:
Johnson Johnson Consumer and Personal Products Worldwide
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of AcetaminophenNaproxen Sodium in Postoperative Dental Pain
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of doses for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen
Detailed Description:
This is a randomized double-blind placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen APAPNaproxen sodium NPX administered as a single two-tablet doseAcetaminophenNaproxen Sodium Dose A AcetaminophenNaproxen Sodium Dose B AcetaminophenNaproxen Sodium Dose C AcetaminophenNaproxen Sodium Dose D AcetaminophenNaproxen Sodium Dose E and Placebo following surgical extraction of four third molars
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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