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Carbonic Anhydrase Inhibitor

Acetazolamide + Methazolamide for Altitude Sickness

Phase 4

Waitlist Available

Research Sponsored by University of Waterloo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the average minute ventilation for each time trial km (1-5) for each arm will be determined. the investigators will be blinded until all participants have completed each trial

Awards & highlights

Study Summary

This trial tests 2 drugs to see if they improve exercise performance in low oxygen conditions. Participants are young, healthy adults who exercise regularly.

Who is the study for?

This trial is for healthy individuals aged 18-40 who exercise regularly, have completed an endurance event in the past year, and can take oral medication. They must not smoke or use cannabis, be pregnant or planning pregnancy, have chronic health conditions, weigh under 49kg or be obese (BMI >30), nor have bleeding disorders or allergies to trial medications.Check my eligibility

What is being tested?

The study tests how Acetazolamide and Methazolamide affect exercise performance at high altitudes compared to a placebo. It's a single-center trial where participants are randomly assigned treatments in a blinded manner and switch between them over time (cross-over).See study design

What are the potential side effects?

Potential side effects of Acetazolamide and Methazolamide may include tingling sensations in fingers/toes, altered taste sensation, frequent urination, drowsiness, confusion, changes in blood sugar levels as well as possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the average minute ventilation for each time trial km (1-5) for each arm will be determined. the investigators will be blinded until all participants have completed each trial

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the average minute ventilation for each time trial km (1-5) for each arm will be determined. the investigators will be blinded until all participants have completed each trial

This trial's timeline: 3 weeks for screening, Varies for treatment, and the average minute ventilation for each time trial km (1-5) for each arm will be determined. the investigators will be blinded until all participants have completed each trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to complete a 5 km time trial after each experimental day (Days 3-5)

Secondary outcome measures

Expired Minute Ventilation

Oxyhemoglobin saturation

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: MethazolamideExperimental Treatment1 Intervention

Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Group II: AcetazolamideActive Control1 Intervention

Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Group III: PlaceboPlacebo Group1 Intervention

Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methazolamide Pill

2023

Completed Phase 4

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wilderness Medical SocietyUNKNOWN

University of WaterlooLead Sponsor

123 Previous Clinical Trials

209,463 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criterion for this trial extend beyond octogenarians?

"This medical research is recruiting subjects of legal age to 40 years old."

Answered by AI

Is this experiment currently recruiting participants?

"Yes, as per the clinicaltrials.gov website, this trial is actively recruiting participants. This research initiative was launched on August 11th 2023 and has since been updated on September 21st of the same year; 15 volunteers are required at a single site for participation."

Answered by AI

Has Methazolamide undergone the necessary validation to be sanctioned by the FDA?

"There is ample clinical data to suggest that Methazolamide is safe; therefore, it was awarded a score of 3."

Answered by AI

What is the total enrolment for this experiment?

"Yes, the details presented on clinicaltrials.gov demonstrate that this medical trial is actively recruiting for participants. This experiment was first posted on August 11th 2023 and its latest update occurred on September 21st 23. Fifteen individuals are required to participate from one facility."

Answered by AI

Are there any criteria that would disqualify someone from taking part in this experiment?

"Fifteen individuals suffering from high altitude sickness aged between 18-40 years old are sought for this clinical trial. Of notable importance, applicants must demonstrate their ability to provide consent and be in general good health; commit to 150 minutes of aerobic exercise each week, take part in physical activity at least twice a week; have recently completed an endurance event up until the last 12 months; accept prescribed oral medication and agree to providing blood samples."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

2023. "Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05575180.