Trial Outcomes & Findings for Maxigesic 325 Acute Dental Pain Study (NCT NCT01420653)
NCT ID: NCT01420653
Last Updated: 2018-12-06
Results Overview
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 expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
408 participants
Primary outcome timeframe
48 hours afte the first dose
Results posted on
2018-12-06
Participant Flow
455 Subjects have been consented and screened, out of which 47 subjects were screening failures and did not receive the first dose of study medication. Among 408 subjects, 273 subjects enrolled from New Zealand sites and 135 subjects enrolled from USA site from May 2013 to Jan 2015.
Participant milestones
| Measure |
Maxigesic 325
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
|
Acetaminophen
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
|
Ibuprofen
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
|
Placebo
Placebo tablets, every 6 hours, orally
Placebo: placebo, three tablets four times a day, with food for 48 hours
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
110
|
111
|
112
|
75
|
|
Overall Study
COMPLETED
|
107
|
108
|
108
|
68
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maxigesic 325 Acute Dental Pain Study
Baseline characteristics by cohort
| Measure |
Maxigesic 325
n=110 Participants
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
|
Acetaminophen
n=111 Participants
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
|
Ibuprofen
n=112 Participants
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
|
Placebo
n=75 Participants
Placebo tablets, every 6 hours, orally
Placebo: placebo, three tablets four times a day, with food for 48 hours
|
Total
n=408 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
24.3 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
24.8 years
STANDARD_DEVIATION 6.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
73 participants
n=5 Participants
|
75 participants
n=7 Participants
|
75 participants
n=5 Participants
|
50 participants
n=4 Participants
|
273 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
37 participants
n=5 Participants
|
25 participants
n=4 Participants
|
135 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 48 hours afte the first dosePopulation: Primary Efficacy Endpoint was analyzed in ITT population (subjects who have been randomized and received the first dose of study medication)
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 expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference.
Outcome measures
| Measure |
Maxigesic 325
n=110 Participants
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
|
Acetaminophen
n=111 Participants
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
|
Ibuprofen
n=112 Participants
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
|
Placebo
n=75 Participants
Placebo tablets, every 6 hours, orally
Placebo: placebo, three tablets four times a day, with food for 48 hours
|
|---|---|---|---|---|
|
SPID (Summed Pain Intensity Differences)
|
31.56 score on a scale
Standard Error 1.94
|
17.71 score on a scale
Standard Error 1.89
|
23.18 score on a scale
Standard Error 1.89
|
14.86 score on a scale
Standard Error 2.26
|
Adverse Events
Maxigesic 325
Serious events: 1 serious events
Other events: 41 other events
Deaths: 1 deaths
Acetaminophen
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maxigesic 325
n=110 participants at risk
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
|
Acetaminophen
n=111 participants at risk
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
|
Ibuprofen
n=112 participants at risk
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
|
Placebo
n=75 participants at risk
Placebo tablets, every 6 hours, orally
Placebo: placebo, three tablets four times a day, with food for 48 hours
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Death due gun shot
|
0.91%
1/110 • Number of events 1 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
0.00%
0/111 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
0.00%
0/112 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
0.00%
0/75 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
Other adverse events
| Measure |
Maxigesic 325
n=110 participants at risk
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
Maxigesic 325: Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
|
Acetaminophen
n=111 participants at risk
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
|
Ibuprofen
n=112 participants at risk
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
Ibuprofen: Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
|
Placebo
n=75 participants at risk
Placebo tablets, every 6 hours, orally
Placebo: placebo, three tablets four times a day, with food for 48 hours
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.6%
15/110 • Number of events 18 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
17.1%
19/111 • Number of events 21 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
13.4%
15/112 • Number of events 15 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
22.7%
17/75 • Number of events 21 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
9/110 • Number of events 10 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
12.6%
14/111 • Number of events 17 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
4.5%
5/112 • Number of events 6 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
9.3%
7/75 • Number of events 8 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
|
Nervous system disorders
Headache
|
7.3%
8/110 • Number of events 10 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
8.1%
9/111 • Number of events 10 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
8.0%
9/112 • Number of events 9 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
9.3%
7/75 • Number of events 8 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
|
Skin and subcutaneous tissue disorders
Facial swelling
|
5.5%
6/110 • Number of events 6 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
9.0%
10/111 • Number of events 10 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
7.1%
8/112 • Number of events 8 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
6.7%
5/75 • Number of events 6 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
|
Nervous system disorders
Diziness
|
3.6%
4/110 • Number of events 4 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
4.5%
5/111 • Number of events 5 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
2.7%
3/112 • Number of events 3 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
6.7%
5/75 • Number of events 5 • Treatment-emergent Adverse Events were collected from the randomization to the follow up telephone contact made at 30 days after the surgery (Surgery Day is Day 1)
The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same as the one from the clinicatrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place