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NCT01420653 · ClinicalTrials.gov registry record · Phase 3

Maxigesic 325 Acute Dental Pain Study

A Phase 3 study, sponsored by AFT Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
408
Enrollment target

NCT01420653: Completed Phase 3 study, sponsored by AFT Pharmaceuticals.

NCT01420653 is a Phase 3 study that has completed, run by AFT Pharmaceuticals. The registered enrollment target is 408 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01420653, a Phase 3 study, has completed, sponsored by AFT Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
408 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.

Primary Outcome

The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication. This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expec

Interventions

  • DRUG Placebo
  • DRUG Acetaminophen
  • DRUG Ibuprofen
  • DRUG Maxigesic 325

Trial Details

FieldValue
Enrollment Target 408 participants
Start Date 2013-04
Est. Completion 2015-01
Phase Phase 3
AFT Pharmaceuticals

6 total trials

What the finished NCT01420653 record still lists

NCT01420653 is an interventional study that assigns participants to a tested intervention. The registered 408 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01420653 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01420653 about?

NCT01420653 is a clinical study titled "Maxigesic 325 Acute Dental Pain Study". The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.

What is the current status of trial NCT01420653?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 408 participants. The study started on 2013-04. Estimated completion is 2015-01.

What interventions are being tested in trial NCT01420653?

The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Ibuprofen (DRUG), Maxigesic 325 (DRUG).

Who is sponsoring clinical trial NCT01420653?

This trial is sponsored by AFT Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01420653's enrollment target sits among peer trials

408 911th of 2000 higher than 1,088 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01420653, the US trial registry maintained by the National Library of Medicine. NCT01420653 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.