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 subjects 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. Subjects 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
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