Status:
COMPLETED
A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
University of Oxford
Wellcome Trust
Conditions:
Acute Mountain Sickness
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 recomm...
Eligibility Criteria
Inclusion
- Nepalese national
- Aged 18 to 65
- Travelling directly from Dhunche to Gosainkunda
- Rapid ascent as defined by ascent within 3 days
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT01418157
Start Date
August 1 2011
End Date
October 1 2011
Last Update
June 24 2013
Active Locations (1)
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1
Oxford University Clinical Research Unit Nepal
Kathmandu, Nepal