Prophylactic sumatriptan for prevention of Acute Mountain Sickness: a double blind, randomised, placebo controlled, clinical trial
ISRCTN | ISRCTN87201238 |
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DOI | https://doi.org/10.1186/ISRCTN87201238 |
Secondary identifying numbers | N/A |
- Submission date
- 23/11/2006
- Registration date
- 14/12/2006
- Last edited
- 07/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sirous Jafarian
Scientific
Scientific
No15, Shabtab Street
Gheytarieh Avenue
Tehran
19389
Iran
Study information
Study design | Single centre, randomised, two-armed, placebo controlled, participants/outcome assessor blind, clinical trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | |
Study acronym | SAMS |
Study objectives | Prophylaxis with sumatriptan will slow or stop the progression of acute mountain sickness (AMS) compared to those taking a placebo. |
Ethics approval(s) | Institutional Review Board of Neurology Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran. |
Health condition(s) or problem(s) studied | Acute mountain sickness |
Intervention | 1. Sumatriptan succinate 50 mg plus orally, once at early ascent 2. Placebo: similar color, shape, and weight to interventional group |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Sumatriptan succinate |
Primary outcome measure | AMS development due to Lake Louise criteria within 24 hours (International Hypoxia Symposium) |
Secondary outcome measures | 1. AMS severity (score more than or equal to five) due to Lake Louise protocol after 24 hours (self-report and clinical assessment) 2. Altitude headache occurrence and severity |
Overall study start date | 01/01/2006 |
Completion date | 30/11/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 102 |
Key inclusion criteria | 1. Age of 18 to 60 years 2. Ascent to a high altitude of 3500 to 3900 metres above sea level from an altitude of at least 1500 metres 3. Consenting participant 4. May reasonably be expected to complete a 24 hour trial |
Key exclusion criteria | 1. Other neuro-vascular disease such as cerebrovascular accident, and hypoxic cerebral damage 2. Cardiovascular disease such as ischaemic heart disease, coronary artery disease, significant valvular disease, congestive heart failure, and uncontrolled hypertension with systolic pressure greater than 180 mmHg or diastolic pressure greater than 110 mmHg 3. Pregnancy 4. Hypersensitivity to either sumatriptan or acetazolamide or their components |
Date of first enrolment | 01/01/2006 |
Date of final enrolment | 30/11/2006 |
Locations
Countries of recruitment
- Iran
Study participating centre
No15, Shabtab Street
Tehran
19389
Iran
19389
Iran
Sponsor information
Imam Neurology Research Center (Iran)
Research organisation
Research organisation
Tehran University of Medical Sciences
No. 23, Dameshgh Street
Vali-e Asr Street
Tehran
14167
Iran
Website | http://iro.tums.ac.ir/ |
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https://ror.org/01c4pz451 |
Funders
Funder type
University/education
Imam Neurology Research Center, Tehran University of Medical Sciences (Iran)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 01/09/2007 | Yes | No |