Trial Outcomes & Findings for Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS) (NCT NCT01171794)

Results Overview

Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

89 participants

Primary outcome timeframe

2 days

Results posted on

2018-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Ibuprofen Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)	Placebo Visually identical placebo
Overall Study STARTED	47	42
Overall Study COMPLETED	44	42
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen n=44 Participants Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)	Placebo n=42 Participants Visually identical placebo	Total n=86 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	42 Participants n=7 Participants	86 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.4 years STANDARD_DEVIATION 14.5 • n=5 Participants	34.2 years STANDARD_DEVIATION 13.2 • n=7 Participants	36.6 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Participants meeting all inclusion criteria were analyzed

Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness

Outcome measures

Outcome measures
Measure	Ibuprofen n=44 Participants Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)	Placebo n=42 Participants visually identical placebo
Acute Mountain Sickness	19 Participants	26 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Participants meeting all inclusion criteria were analyzed

Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms

Outcome measures

Outcome measures
Measure	Ibuprofen n=44 Participants Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)	Placebo n=42 Participants visually identical placebo
Acute Mountain Sickness Severity	3.2 units on a scale Standard Deviation 2.4	4.4 units on a scale Standard Deviation 2.6

Adverse Events

Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Grant S Lipman ( PI)

Stanford University School of Medicine

Phone: 4152909286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place