Acute Mountain SicknessPhase 4NCT01418157
A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent
A Phase 4 study testing Acetazolamide in people with Acute Mountain Sickness, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Nepal.
Trial summary
Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Acetazolamide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteNepal
- Study dates
- Aug 2011to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nepalese national
- Aged 18 to 65
- Travelling directly from Dhunche to Gosainkunda
- Rapid ascent as defined by ascent within 3 days
Who cannot join
- Use of any drugs for the prevention of altitude sickness or headache
- Current illness
- Current altitude sickness (more than one mild symptom on the Lake Louise Questionnaire (LLQ), or oxygen saturation less than 75%
- Known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days
- One night within the last 30 days spent at an altitude of 4500 metres or above
- Residents of altitude more than 2500m
Show all 11Show fewer
- A known drug allergy to sulfonamides.
- Treatment with any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (Lasix®), ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen.
- Any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri
- Known severe uncontrolled headache syndrome
- Diagnosed renal function impairment, diabetes, cirrhosis of liver or liver dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent
Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter.
This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations.
Read more
This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue.
The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.
- Conditions
- Acute Mountain Sickness
- Being tested
- Acetazolamide, Placebo
- Keywords
- Acute mountain sickness, Rapid ascent, High altitude headache, Mountain Medicine Society Nepal
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
125 mg twice daily until 4380 meters altitude
PlaceboDrug
Twice daily
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Active comparator | Not described Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of acute mountain sickness
A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
Measured: Upon reaching an altitude of 3300m, average expected time is 1 day
Diagnosis of acute mountain sickness
A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
Measured: Upon reaching an altitude of 4380m, average expected time is 3 days
Secondary outcomes (6)
Blood oxygen saturation
Percent
Measured: Upon reaching an altitude of 3300m, average expected time is 1 day
Heart rate
Beats per minute
Measured: Upon reaching an altitude of 3300m, average expected time is 1 day
High altitude headache
High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
Measured: Upon reaching an altitude of 3300m, average expected time is 1 day
Blood oxygen saturation
Percent
Measured: Upon reaching an altitude of 4380m, average expected time is 3 days
Heart rate
Beats per minute
Measured: Upon reaching an altitude of 4380m, average expected time is 3 days
High altitude headache
High altitude headache severity will be scored in millimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
Measured: Upon reaching an altitude of 4380m, average expected time is 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust, Mountain Medicine Society of Nepal
- Responsible party
- Sponsor
- Investigators
- Buddha Basnyat, MD PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418157
- Sponsor's protocol ID
- 04NP
- Status last verified
- Jun 2013
- First submitted
- 8 Aug 2011
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gertsch JH, Corbett B, Holck PS, Mulcahy A, Watts M, Stillwagon NT, Casto AM, Abramson CH, Vaughan CP, Macguire C, Farzan NN, Vo BN, Norvelle RJ, May K, Holly JE, Irons H, Stutz AM, Chapagain P, Yadav S, Pun M, Farrar J, Basnyat B. Altitude Sickness in Climbers and Efficacy of NSAIDs Trial (ASCENT): randomized, controlled trial of ibuprofen versus placebo for prevention of altitude illness. Wilderness Environ Med. 2012 Dec;23(4):307-15. doi: 10.1016/j.wem.2012.08.001. Epub 2012 Oct 24.
PubMed 23098412
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Placebo Controlled Randomised Trial of Acetazolamide Versus Placebo in the Prevention of Acute Mountain Sickness During Rapid Ascent
- ClinicalTrials.gov ID
- NCT01418157
- Acronym / sponsor ID
- 04NP
- Conditions
- Acute Mountain Sickness
- Keywords
- Acute mountain sickness, Rapid ascent, High altitude headache, Mountain Medicine Society Nepal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- University of Oxford, Wellcome Trust, Mountain Medicine Society of Nepal
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter.
This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations.
This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue.
The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Active comparator | Drug: Acetazolamide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nepalese national
- Aged 18 to 65
- Travelling directly from Dhunche to Gosainkunda
- Rapid ascent as defined by ascent within 3 days
Key exclusion criteria (11 listed)
- Use of any drugs for the prevention of altitude sickness or headache
- Current illness
- Current altitude sickness (more than one mild symptom on the Lake Louise Questionnaire (LLQ), or oxygen saturation less than 75%
- Known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days
- One night within the last 30 days spent at an altitude of 4500 metres or above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetazolamide125 mg twice daily until 4380 meters altitude | Drug | Acetazolamide |
| PlaceboTwice daily | Drug | Placebo |
Primary outcome
Diagnosis of acute mountain sickness
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
Diagnosis of acute mountain sickness
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
6 secondary outcomes
Blood oxygen saturation
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
Heart rate
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
High altitude headache
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
Blood oxygen saturation
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
Heart rate
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
High altitude headache
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Results publication: PubMed 23098412Gertsch JH, Corbett B, Holck PS, Mulcahy A, Watts M, Stillwagon NT, Casto AM, Abramson CH, Vaughan CP, Macguire C, Farzan NN, Vo BN, Norvelle RJ, May K, Holly JE, Irons H, Stutz AM, Chapagain P, Yadav S, Pun M, Farrar J, Basnyat B. Altitude Sickness in Climbers and Efficacy of NSAIDs Trial (ASCENT): randomized, controlled trial of ibuprofen versus placebo for prevention of altitude illness. Wilderness Environ Med. 2012 Dec;23(4):307-15. doi: 10.1016/j.wem.2012.08.001. Epub 2012 Oct 24.
- Mountain Medicine Society NepalLink provided by the sponsor.
- Oxford University Clinical Research Unit Viet NamLink provided by the sponsor.
- Oxford University Clinical Research Unit NepalLink provided by the sponsor.
- Trial Informed Consent Form, approvals and additional informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buddha Basnyat, MD PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetazolamide in people with Acute Mountain Sickness, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of acute mountain sickness (time frame: Upon reaching an altitude of 3300m, average expected time is 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01418157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.