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

ISRCTN	ISRCTN26123577
DOI	https://doi.org/10.1186/ISRCTN26123577
Secondary identifying numbers	86-01-54-5304

Submission date: 26/02/2007
Registration date: 27/03/2007
Last edited: 18/02/2008

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

No. 15, Shabtab Street
Gheytarieh Avenue
Tehran
19389
Iran

Phone	+98 (0)91 2215 6750
Email	jafarian_s@yahoo.com

Study information

Study design	Single centre, randomised, parallel group, two-armed, placebo controlled, participants/outcome assessor blinded, clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	GPAMS
Study objectives	Prophylaxis with gabapentin will slow or stop the progression of Acute Mountain Sickness (AMS) compared to those taking a placebo.
Ethics approval(s)	Approval received from the institutional review board of the Neurology Research Centre, Imam Hospital, Tehran University of Medical Sciences (Iran) on the 11th Januray 2007 (ref: 85-04-54-4708).
Health condition(s) or problem(s) studied	Acute mountain sickness
Intervention	Treatment group one: gabapentin 600 mg orally; single dose within first two hours of ascent. Treatment group two: mono-hydrate lactose (same shape and weight to gabapentin capsules); single dose within first two hours of ascent.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gabapentin
Primary outcome measure	1. AMS incidence (Lake Louise acute mountain sickness score of equal or more than three with headache and at least one other symptom) 2. AMS severity (score of five or more)
Secondary outcome measures	1. Duration of high-altitude headache free phase after prophylaxis initiation 2. Duration of moderate to severe high-altitude headache free phase after prophylaxis
Overall study start date	15/02/2007
Completion date	15/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	204
Key inclusion criteria	1. Age of 15 to 65 years 2. Ascent to a high altitude of 3500 to 3900 metres above sea level from an altitude of at least 1500 metres using cable cars (within 45 to 90 minutes) 3. Consenting participant 4. May reasonably be expected to complete a 24 hour trial
Key exclusion criteria	1. Severe cardiac, pulmonary, or liver disease 2. Severely impaired kidney function 3. Current history of alcohol or drug abuse 4. Pregnancy 4. Known allergy to gabapentin 5. Treatment with anticonvulsants or tricyclic antidepressants
Date of first enrolment	15/02/2007
Date of final enrolment	15/03/2007

Locations

Countries of recruitment

Iran

Study participating centre

No. 15, Shabtab Street

Tehran
19389
Iran

Sponsor information

Tehran University of Medical Sciences (Iran)
University/education

c/o Professor Ghaffarpour
Neurology Research Centre
Imam Hospital
Faculty of Medicine
Keshavarz Blvd
Tehran
19389
Iran

Website	http://www.tums.ac.ir/index.html
"ROR"	https://ror.org/01c4pz451

Funders

Funder type

Industry

Tehran University of Medical Sciences (Iran)

No information available

Darou Darman Pars Pharmaceuticals (DDP) (Iran)

No information available

Results and Publications

Intention to publish date
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?
Results article	Results	01/03/2008		Yes	No