Condition category
Oral Health
Date applied
09/06/2010
Date assigned
24/06/2010
Last edited
18/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Stephen Daniels

ORCID ID

Contact details

SCIREX Research Center/ Premier Research Group
3200 Red River
Suite 300
Austin
TX 78705
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL0408

Study information

Scientific title

Comparing the analgesic efficacy of Advil® and Tylenol® Extra Strength, separately and in combination, in patients experiencing postoperative dental pain: A double blind, randomised, placebo controlled, parallel group trial with modified factorial design

Acronym

Study hypothesis

The objective of this study was to compare the analgesic efficacy of Advil® tablets (200 or 400 mg ibuprofen) given concurrently with Tylenol® Extra Strength (ES) caplets (500 or 1000 mg acetaminophen [paracetamol]) to:
1) Advil tablets (400mg ibuprofen) alone;
2) Tylenol ES caplets (1000mg acetaminophen) alone;
3) Placebo
among subjects experiencing moderate to severe postoperative dental impaction pain. Analgesic efficacy was measured in terms of total effect, peak effect, onset and duration of effect, and subject’s overall assessment of the study medication.

A secondary objective was to evaluate the tolerability (adverse event [AE] profile) of the combination of Advil tablets (200 or 400 mg ibuprofen) given concurrently with Tylenol Extra Strength (500 or 1000 acetaminophen) to the individual ingredients and to placebo.

Ethics approval

Quorum Review (Seattle, WA) independent institutional review board (IRB) approved on the 8th of October 2004

Study design

Randomised double blind placebo controlled single dose modified factorial design study using the dental impaction pain model

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Dental Pain

Intervention

Subjects were randomly allocated to one of the 5 treatment groups:
1. 400mg Ibuprofen alone
2. 1000mg Acetaminophen alone
3. 400mg Ibuprofen plus 1000mg acetaminophen
4. 200mg Ibuprofen plus 500mg acetaminophen
5. Placebo

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Sum of Pain Relief and Pain Intensity Differences from 0-8 hours (SPRID 0-8)

Secondary outcome measures

1. Total Pain Relief from 0 to 8 hours (TOTPAR 0-8)
2. Sum of the Pain Intensity Differences from 0 to 8 hours (SPID 0-8)
3. Sum of the Pain Intensity Differences on the VAS scale from 0 to 8 hours (SPID VAS 0-8)
4. TOTPAR, SPID, SPRID, and SPID VAS from 0 to 4 hours (0-4) and 0 to 6 hours (0-6)
5. Individual pain relief (PR) readings at each time point from 15 minutes to 8 hours
6. Peak PR recorded during the 8-hour evaluation period
7. Individual PID at each time point from 15 minutes to 8 hours
8. Individual PID for the VAS scale (PID VAS) at each time point from 15 minutes to 8 hours
9. Peak PID and peak PID VAS recorded during the 8-hour evaluation period
10. First time at which the PID was at least 1
11. Time to first perceptible pain relief
12. Time to first confirmed perceptible pain relief
13. Time to first meaningful pain relief
14. Time to use of rescue medication
15. Time to pain half gone
16. Subject’s overall (global) assessment

Overall trial start date

02/11/2004

Overall trial end date

15/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: between the ages of 16 and 40 years of age
2. Sex: either male or female
3. Primary diagnosis: At least three impacted third molars (two of which must have been mandibular impacted molars) indicated for removal. Both mandibular impactions must have required bone removal, and there must have been a total score of 9 or greater on the impaction grading scale for the three or four impacted third molar
4. Baseline Pain Intensity: were experiencing postoperative pain of at least moderate based on the pain intensity categorical rating scale and a pain intensity VAS score of 50mm or greater on the 100mm VAS Scale
5. Consent: gave written informed consent. Subjects who were 16 or 17 years of age also required their parents or legal guardian to provide written informed consent in addition to their written assent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Analysed: 234

Participant exclusion criteria

1. Had a current history of significant disease deemed by the investigator to render the subject unsuitable for inclusion
2. Had any ongoing painful condition other than that associated with their third molar surgery
3. Had an ongoing condition that may have interfered with the absorption, distribution, metabolism or excretion of the study drug
4. Had a history of allergy (including angioedema, urticaria, bronchospasm and rhinitis) related to the treatment with ibuprofen, acetaminophen, aspirin, other NSAIDs or any other medication used in this study
5. A history of frequent peptic ulcers, duodenal ulcers or GI bleeding
6. A history of frequent dyspepsia, heartburn or indigestion
7. A history of migraine headaches within the past year
8. A history of psychotic illness, attempted suicide or neurosis
9. Those unable to refrain from smoking during their stay in the research centre
10. A positive history of drug or alcohol abuse within the past six months
11. Those who were taking any concomitant medication that might have confounded assessments of pain relief (PAR), such as: psychotropic drugs, antidepressants, sedative-hypnotics (other than those permitted for conscious sedation), or other analgesics taken within five times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs) were permitted if the subject had been on a stable dose for at least four weeks prior to visit 1 (screening)
12. Those who were unable, in the opinion of the investigator, to comply fully with the study requirements
13. Those previously randomised into this study
14. Those who had participated in a clinical trial in the previous 12 weeks. Twelve weeks (calculated from the time of last dosing in the prior trial to time of anticipated dosing in this trial)

Recruitment start date

02/11/2004

Recruitment end date

15/02/2005

Locations

Countries of recruitment

United States of America

Trial participating centre

SCIREX Research Center/ Premier Research Group
Austin
TX 78705
United States of America

Sponsor information

Organisation

Reckitt Benckiser Healthcare (UK)

Sponsor details

Dansom Lane
Hull
HU8 7DS
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Reckitt Benckiser Healthcare (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes