Prophylactic sumatriptan for prevention of Acute Mountain Sickness: a double blind, randomised, placebo controlled, clinical trial

ISRCTN ISRCTN87201238
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

No15, Shabtab Street
Gheytarieh Avenue
Tehran
19389
Iran

Study information

Study designSingle centre, randomised, two-armed, placebo controlled, participants/outcome assessor blind, clinical trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymSAMS
Study objectivesProphylaxis 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) studiedAcute mountain sickness
Intervention1. Sumatriptan succinate 50 mg plus orally, once at early ascent
2. Placebo: similar color, shape, and weight to interventional group
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Sumatriptan succinate
Primary outcome measureAMS development due to Lake Louise criteria within 24 hours (International Hypoxia Symposium)
Secondary outcome measures1. 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 date01/01/2006
Completion date30/11/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants102
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2006
Date of final enrolment30/11/2006

Locations

Countries of recruitment

  • Iran

Study participating centre

No15, Shabtab Street
Tehran
19389
Iran

Sponsor information

Imam Neurology Research Center (Iran)
Research organisation

Tehran University of Medical Sciences
No. 23, Dameshgh Street
Vali-e Asr Street
Tehran
14167
Iran

Website http://iro.tums.ac.ir/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/09/2007 Yes No