Condition category
Injury, Occupational Diseases, Poisoning
Date applied
26/02/2007
Date assigned
27/03/2007
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sirous Jafarian

ORCID ID

Contact details

No. 15
Shabtab Street
Gheytarieh Avenue
Tehran
19389
Iran
+98 (0)91 2215 6750
jafarian_s@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

86-01-54-5304

Study information

Scientific title

Acronym

GPAMS

Study hypothesis

Prophylaxis with gabapentin will slow or stop the progression of Acute Mountain Sickness (AMS) compared to those taking a placebo.

Ethics approval

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).

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Gabapentin

Primary outcome measures

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 trial start date

15/02/2007

Overall trial end date

15/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

204

Participant 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

Recruitment start date

15/02/2007

Recruitment end date

15/03/2007

Locations

Countries of recruitment

Iran

Trial participating centre

No. 15, Shabtab Street
Tehran
19389
Iran

Sponsor information

Organisation

Tehran University of Medical Sciences (Iran)

Sponsor details

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

Sponsor type

University/education

Website

http://www.tums.ac.ir/index.html

Funders

Funder type

Industry

Funder name

Tehran University of Medical Sciences (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Darou Darman Pars Pharmaceuticals (DDP) (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17965148

Publication citations

  1. Results

    Jafarian S, Abolfazli R, Gorouhi F, Rezaie S, Lotfi J, Gabapentin for prevention of hypobaric hypoxia-induced headache: randomized double-blind clinical trial., J. Neurol. Neurosurg. Psychiatr., 2008, 79, 3, 321-323, doi: 10.1136/jnnp.2007.124727.

Additional files

Editorial Notes