Altitude Sickness Prevention With Ibuprofen Relative to A... | NCT03154645

Studies
Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

NCT03154645

Sponsor

Grant S Lipman

Status

Completed

Last Update Posted

Nov 26, 2018Actual

Enrollment

92Actual

Phase

Phase 1

Conditions

Acute Mountain Sickness

Interventions

Ibuprofen
Acetazolamide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 12, 2017Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

May 11, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 16, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2018

Last Update Posted Date

Nov 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grant S Lipman, Principal Investigator, Stanford UniversitySponsor-Investigator

Lead Sponsor

Grant S LipmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.

Detailed Description

The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ibuprofen	Active Comparator	ibuprofen, 600mg, three times a day, through to ascent to high altitude	Drug: Ibuprofen
acetazolamide	Active Comparator	acetazolamide, 125mg, two times a day, through to ascent to high altitude	Drug: Acetazolamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug	non-steroidal anti-inflammatory drug	Ibuprofen	Motrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of acute mountain sickness	incidence of acute mountain sickness by Lake Louise Questionnaire	2 days

Secondary Outcomes

Measure	Description	Time Frame
severity of acute mountain sickness	severity of acute mountain sickness by Lake Louise Questionnaire (0-15)	2 days
oxygen saturation	measurement of oxygen saturation (%) by fingertip pulse oximetry

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 healthy non-pregnant volunteer
Sea-level dwelling (live at low elevation < 4000 ft)
Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
Available for full study duration (Friday PM-Sunday AM)

Exclusion Criteria:

Age <18 or >65, Pregnant, Live at altitude >4000 ft
Slept at altitude > 4000ft within 1 week of study
Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
White Mountain Research Station		Bishop	California	93515	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30419226	Result	Burns P, Lipman GS, Warner K, Jurkiewicz C, Phillips C, Sanders L, Soto M, Hackett P. Altitude Sickness Prevention with Ibuprofen Relative to Acetazolamide. Am J Med. 2019 Feb;132(2):247-251. doi: 10.1016/j.amjmed.2018.10.021. Epub 2018 Nov 10.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals