Mountain SicknessPhase 1NCT01587027
Safety Evaluation of Aminophylline and Methazolamide
A Phase 1 study testing Aminophylline, Methazolamide and Aminophylline and Methazolamide in people with Mountain Sickness, run by Poudre Valley Health System at 1 site in United States.
Trial summary
This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Mountain Sickness
- What is being tested?
- Aminophylline, Methazolamide and Aminophylline and Methazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be healthy non-smoking adult male and female volunteers between the ages of 18 and 40 years, with a BMI of 18-30 kg/m2 and weighting at least 150 lbs. Women who are of childbearing potential, must, if sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for one (1) month afterwards.
- Subjects must agree not to donate blood, plasma, platelets, or any other blood components during the study and for 4 weeks after the last dose.
Who cannot join
- History or manifestation of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematologic or other medical disorders.
- Serious mental or physical illness within the past year.
- History of clinically significant illness within 4 weeks prior to Day 1.
- History of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives.
- Use of any of the following:
- Any concomitant medication. Subjects who have received any prescribed or non-prescribed (over-the-counter [OTC]) systemic medication, topical medications, or herbal supplements within 14 days from Day 1. St. John's Wort (hypericin) must not have been taken for at least 30 days prior to Period 1, Day 1.
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- Any drugs, foods or substances known to be strong inhibitors or strong inducers of CYP enzymes (also known as cytochrome P450 enzymes); especially CYP 1A2, or Pgp within 30 days prior to Period 1, Day 1.
- Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years.
- Positive results on screening tests for drugs of abuse, cotinine or alcohol at screening or the pre-dose assessment at check-in.
- Clinically significant ECG abnormality, in the opinion of the Investigator.
- Use of tobacco products or other nicotine-containing products (including smoking cessation aids, such as gums or patches) with in 14 days of screening and throughout hospitalization.
- Subjects of childbearing potential who are pregnant (as based on test results) or are breast feeding.
- Has taken any other investigational drug during the 30 days prior to the screening visit or is currently participating in another investigational clinical trial.
- Subjects who have made any significant donation (including plasma) or have had a significant loss of blood within 30 days prior to Period 1, Day 1.
- Receipt of a transfusion or any blood products within 30 days prior to Period 1, Day 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Official title: The Safety Evaluation of Aminophylline and Methazolamide When Administered Orally Alone and in Combination to Healthy Volunteers
This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.
Read the detailed description
After successful completion of this safety trial, our goal will be to evaluate the safety of this combination in healthy individuals exposed to hypoxia and exercise. Subsequently, an efficacy study will clarify whether this drug combination improves physical and mental functions in human subjects under high altitude conditions.
- Conditions
- Mountain Sickness
- Being tested
- Aminophylline, Methazolamide, Aminophylline and Methazolamide
- Keywords
- Altitude Sickness, High Altitude Sickness
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminophyllineDrug
Also called theophylline
Aminophylline dosage form-tablet dosage-500mg
MethazolamideDrug
Also called Neptazane
Methazolamide dosage form-tablet dosage-250mg
Aminophylline and MethazolamideDrug
Also called theophylline, Neptazane
Aminophylline 500mg orally and Methazolamide 250mg orally
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Active comparator | Aminophylline, Methazolamide, Aminophylline and Methazolamide Receives: Drug: Aminophylline; Drug: Methazolamide; Drug: Aminophylline and Methazolamide |
| Sequence B | Active comparator | Methazolamide, Aminophylline, Aminophylline and Mathazolamide Receives: Drug: Aminophylline; Drug: Methazolamide; Drug: Aminophylline and Methazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events.
Adverse event data was evaluated for incidence and severity for 6 days.
Measured: 6 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency, University of Colorado, Denver
- Responsible party
- Principal investigator, Gary J. Luckasen, MD, Poudre Valley Health System
- Investigators
- Gary Luckasen, M.D., Principal investigator, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587027
- Sponsor's protocol ID
- GQ01 DARPA
- Status last verified
- Dec 2016
- First submitted
- 16 Apr 2012
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety Evaluation of Aminophylline and Methazolamide When Administered Orally Alone and in Combination to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01587027
- Acronym / sponsor ID
- GQ01 DARPA
- Conditions
- Mountain Sickness
- Keywords
- Altitude Sickness, High Altitude Sickness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency, University of Colorado, Denver
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This safety study is the first in a series of studies testing the application of the combination of aminophylline and methazolamide.
Detailed description
After successful completion of this safety trial, our goal will be to evaluate the safety of this combination in healthy individuals exposed to hypoxia and exercise. Subsequently, an efficacy study will clarify whether this drug combination improves physical and mental functions in human subjects under high altitude conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Active comparator | Drug: Aminophylline, Drug: Methazolamide, Drug: Aminophylline and MethazolamideAminophylline, Methazolamide, Aminophylline and Methazolamide |
| Sequence B | Active comparator | Drug: Aminophylline, Drug: Methazolamide, Drug: Aminophylline and MethazolamideMethazolamide, Aminophylline, Aminophylline and Mathazolamide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects must be healthy non-smoking adult male and female volunteers between the ages of 18 and 40 years, with a BMI of 18-30 kg/m2 and weighting at least 150 lbs. Women who are of childbearing potential, must, if sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for one (1) month afterwards.
- Subjects must agree not to donate blood, plasma, platelets, or any other blood components during the study and for 4 weeks after the last dose.
Key exclusion criteria (15 listed)
- History or manifestation of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematologic or other medical disorders.
- Serious mental or physical illness within the past year.
- History of clinically significant illness within 4 weeks prior to Day 1.
- History of allergic reaction, hypersensitivity or idiosyncratic reaction to any of the products administered during the study, including allergy to any sulfa or sulfonamide derivatives.
- Use of any of the following:
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 |
|---|---|---|
| AminophyllineAlso: theophyllineAminophylline dosage form-tablet dosage-500mg | Drug | Sequence A, Sequence B |
| MethazolamideAlso: NeptazaneMethazolamide dosage form-tablet dosage-250mg | Drug | Sequence A, Sequence B |
| Aminophylline and MethazolamideAlso: theophylline, NeptazaneAminophylline 500mg orally and Methazolamide 250mg orally | Drug | Sequence A, Sequence B |
Primary outcome
Adverse Events.
Time frame: 6 days.
Adverse event data was evaluated for incidence and severity for 6 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mountain Sickness
Not yet recruiting
High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
High-altitude Pulmonary Edema
Not yet recruitingObservational study
Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
Neonatal Congenital Heart Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals
High Altitude, Healthy
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.
Gary Luckasen, M.D. principal investigator
Poudre Valley Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aminophylline, Methazolamide and Aminophylline and Methazolamide in people with Mountain Sickness, run by Poudre Valley Health System at 1 site in United States.
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 2 inclusion and 15 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 10 Feb 2017. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events. (time frame: 6 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.