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Trial Outcomes & Findings for Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood (NCT NCT01756209)

NCT ID: NCT01756209

Last Updated: 2020-03-25

Results Overview

The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours. Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

160 participants

Primary outcome timeframe

3 and 18 months

Results posted on

2020-03-25

Participant Flow

Participant milestones

Participant milestones
Measure
Acetaminophen
Acetaminophen 15 mg/kg oral single dose
Ibuprofen
Ibuprofen 10 mg/kg oral single dose
Mg + Acetaminophen
Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
Mg + Ibuprofen
Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
Overall Study
STARTED
40
40
40
40
Overall Study
COMPLETED
40
40
40
40
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Acetaminophen
n=40 Participants
Acetaminophen 15 mg/kg oral single dose
Ibuprofen
n=40 Participants
Ibuprofen 10 mg/kg oral single dose
Mg + Acetaminophen
n=40 Participants
Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
Mg + Ibuprofen
n=40 Participants
Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
Total
n=160 Participants
Total of all reporting groups
Age, Categorical
<=18 years
40 Participants
n=5 Participants
40 Participants
n=7 Participants
40 Participants
n=5 Participants
40 Participants
n=4 Participants
160 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
20 Participants
n=7 Participants
20 Participants
n=5 Participants
20 Participants
n=4 Participants
80 Participants
n=21 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
20 Participants
n=7 Participants
20 Participants
n=5 Participants
20 Participants
n=4 Participants
80 Participants
n=21 Participants
Region of Enrollment
Italy
40 participants
n=5 Participants
40 participants
n=7 Participants
40 participants
n=5 Participants
40 participants
n=4 Participants
160 participants
n=21 Participants
pain visual analog scale (range 0 (better) -100 (worse) mm)
6.95 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
6.55 units on a scale
STANDARD_DEVIATION 2.85 • n=7 Participants
7.57 units on a scale
STANDARD_DEVIATION 2.55 • n=5 Participants
7.35 units on a scale
STANDARD_DEVIATION 2.93 • n=4 Participants
7.11 units on a scale
STANDARD_DEVIATION 2.81 • n=21 Participants

PRIMARY outcome

Timeframe: 3 and 18 months

The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours. Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)

Outcome measures

Outcome measures
Measure
Acetaminophen
n=40 Participants
Acetaminophen 15 mg/kg oral single dose
Ibuprofen
n=40 Participants
Ibuprofen 10 mg/kg oral single dose
Mg + Acetaminophen
n=40 Participants
Magnesium 400 mg/daily + Acetaminophen 15 mg/kg oral single dose
Mg + Ibuprofen
n=40 Participants
Magnesium 400 mg/daily + Ibuprofen 10 mg/kg oral single dose
Pain-relief
5.6 units on a scale*hr
Standard Deviation 0.5
5.1 units on a scale*hr
Standard Deviation 0.6
2.25 units on a scale*hr
Standard Deviation 0.3
2.2 units on a scale*hr
Standard Deviation 0.4

Adverse Events

Acetaminophen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ibuprofen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Mg + Acetaminophen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Mg + Ibuprofen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Francesco Peltrone, Responsible of clinical trial

Pugliese Hospital of Catanzaro

Phone: +.39 0961 7123222

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place