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PI was unable to continue to gather data during the trip during to medical illness
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The overall goal of this study is to detect preclinical signs of HAPE by lung ultrasonography and evaluate the effectiveness of acetazolamide at decreasing pulmonary edema by using ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide normal dose | Experimental | One (1) dose of 250mg of Acetazolamide |
|
| Placebo | Placebo Comparator | One (1) dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Administration of Acetazolamide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Edema Before and After Taking Acetazolamide | Edema measured through ultrasound exam | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Completion of Ultrasound Exams | Time it takes to complete ultrasound exams | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Irons, MD, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01655 | United States |
No ipd to share.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetazolamide Normal Dose | One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide |
| FG001 | Placebo | One (1) dose of placebo Placebo: Administration of Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants were enrolled, but no participants were randomized to intervention and no participants received intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetazolamide Normal Dose | One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide |
| BG001 | Placebo | One (1) dose of placebo Placebo: Administration of Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pulmonary Edema Before and After Taking Acetazolamide | Edema measured through ultrasound exam | No participants were randomized and no participants received intervention. | Posted | 1 month |
|
|
Due to investigator illness, no participants were randomized and no study drug was administered.
Due to investigator illness, no participants were randomized and no study drug was administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetazolamide Normal Dose | One (1) dose of 250mg of Acetazolamide Acetazolamide: Administration of Acetazolamide |
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Due to Investigator illness, although participants were enrolled, no participants were randomized to receive interventions and did not receive study drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | UMass Medical School | 4136279111 | vincent.kan08@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2018 | Apr 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Administration of Placebo |
|
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
| Counts |
|---|
| Participants |
|
| Secondary | Time to Completion of Ultrasound Exams | Time it takes to complete ultrasound exams | Participants enrolled but not randomized and did not receive study drug. | Posted | 1 month |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | One (1) dose of placebo Placebo: Administration of Placebo | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |