Clinical Trials

Goals

To find out why the identifier, NCT03722238 — which represents the study for the actual use and compliance study of Ibuprofen 600 mg immediate release/extended release tablets in at-risk OTC consumers — was suspended. Specifically, if it was suspended over a regulatory issue or the Coronavirus. This will be used to evaluate a project.

Early Findings

Basic Details and Enrollment

  • Sponsored by Pfizer, the identifier, NCT03722238, represents the clinical trial for the multicenter actual use and compliance study of Ibuprofen 600 mg immediate release/extended release tablets among targeted (at-risk) consumers in a simulated over-the-counter environment.
  • The study/clinical trials began on December 27, 2018, and was originally scheduled to end on October 30, 2020. The last update was made on June 5, 2020.
  • Among other secondary outcome measures, the primary outcome measure is to evaluate the proportion of subjects who exceed the maximum daily dose (1200 mg) on two or more calendar days during the use period.
  • Among other enrollment requirements, potential enrollees must be 12 years and older, either male or female, and must be healthy volunteers — of which "the total number of subjects expected to enroll into the study was approximately 820 with sites at pharmacies in diverse geographic locations around the US."
  • The study was in phase III prior to the suspension of the study.
  • While the recruitment status shows that the study has been suspended based on the "management's decision to temporarily suspend enrollment while the program is reassessed," no specific or detailed reason is provided on the database.

Possible Reasons for Suspension

  • According to a database curated by Benjamin Gregory Carlisle, PhD, on the impacts of Covid-19 on clinical trials, the identifier (NCT03722238) is listed: however, while there are some paused/suspended studies from the explicit impact of Covid-19, the requested identifier (NCT03722238) had no such direct indication. Only similar reasons provided in the Clinical Trials database was provided.
  • However, to date, 1,425 clinical trials have been stopped due to Covid-19.
  • Other clinical trial database, such as Good Clinical Practice Network, also provides no reason towards the suspension of the study.
  • Research into the press section and releases of Pfizer and the US clinical trial agency provides that both stakeholders are yet to make any announcement, together with other third-party media sources

Summary

To wrap up, it appears that there's no publicly available information on why the requested study or identifier was suspended, as the closest information only suggests that it may be die to Covid-19.

Proposed next steps:

You need to be the project owner to select a next step.