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Maxi-Analgesic Phase 2 Study to Compare the Analgesic Effects in Different Dosing Groups to Treat Teeth Extraction Pain

NCT01104844 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-07-12

No results posted yet for this study

Summary

The aim of the study is to examine the dose response relationship in the treatment of dental pain (teeth extraction) for the different potential doses of the investigational drug, i.e. 2 tablets, 1 tablet or ½ a tablet given 4 times a day.

Conditions

  • Dental Pain

Interventions

DRUG

Full Dose Strength

Acetaminophen + ibuprofen, 2 tablets every 6 hours, with food for 24 hours (i.e a total of 4 x 1000/300 mg doses of study drug comprising of 8 tablets)

DRUG

Quarter dose strength

Investigational drug quarter dose strength (acetaminophen 125mg + ibuprofen 37.5mg) i.e. 2 tablets equating to 1/4 the dose in the standard investigational drug.

DRUG

Half dose strength

Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug

DRUG

Acetaminophen standard dose

Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug

DRUG

Ibuprofen low dose

Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product

DRUG

Ibuprofen high dose

Ibuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug

DRUG

Placebo

2 placebo tablets

Sponsors & Collaborators

  • AFT Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Kuss, Doctor · Premier Research Group Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01104844 on ClinicalTrials.gov