Acute Mountain SicknessNCT01522326
Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness
A study testing Ibuprofen and Metoclopramide in people with Acute Mountain Sickness and High Altitude Headache, run by Massachusetts General Hospital at 1 site in Nepal.
Trial summary
The objective of this study is to determine the efficacy of metoclopramide in relieving the symptoms of Acute Mountain Sickness (AMS). It is our hypothesis that the combined antiemetic and analgesic effects of metoclopramide (which has been study-proven to be effective in relieving symptoms of migraine headache) will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness, High Altitude Headache
- What is being tested?
- Ibuprofen and Metoclopramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNepal
- Study dates
- 1 Mar 2012to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence at Manang recruitment center (at approximately 11,500 ft) during the dates March through May, 2012.
- Recent increase in altitude of > 1000 ft vertical in last 24 hours
- Presence of headache and at least one other symptom required for diagnosis of acute mountain sickness (including nausea, vomiting, fatigue, weakness, dizziness, lightheadedness or poor sleeping.)
Who cannot join
- Age less than 19 years old
- Known allergy or contraindication to either ibuprofen or metoclopramide
- Evidence of severe high altitude illness (e.g. High altitude pulmonary edema (HAPE) as evidenced by dyspnea at rest -- or of High Altitude Cerebral Edema (HACE) as evidenced by altered mental status or ataxia)
- Known or suspected pregnancy
- Use of other analgesic or antiemetic within 8 hours of study enrollment
- History of migraines or other chronic headache disorders
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Manang Clinic of the Himalayan Rescue Association
Manang, District of Manang, 33500
About this study
Official title: Acute Mountain Sickness Treatment: A Double-blind Comparison of Metoclopramide vs. Ibuprofen
The objective of this study is to determine the efficacy of metoclopramide in relieving the symptoms of Acute Mountain Sickness (AMS).
It is our hypothesis that the combined antiemetic and analgesic effects of metoclopramide (which has been study-proven to be effective in relieving symptoms of migraine headache) will prove to be more efficacious in relieving symptoms of acute mountain sickness than the standard, previously-studied analgesic medication, ibuprofen.
Read the detailed description
Acute Mountain Sickness (AMS) is a well described disease process that occurs as a result of rapid exposure to high altitude. High altitude headache (HAH) is defined as the presence of headache in the setting of a recent increase in altitude. When HAH is associated with nausea, vomiting, fatigue, weakness, dizziness, lightheadedness or poor sleeping, AMS is diagnosed. While benign, AMS is very common, afflicting up to 80 % of travelers who ascend rapidly to 14,000 ft, and can be debilitating. AMS is thought to occur secondary to hypoxia-induced cerebral vasodilation. The antiemetic metoclopramide has been well studied and is commonly administered for treatment of migraine headaches in emergency departments across the U.S. The symptoms of migraine headaches are often similar to those of AMS. The mechanism of metoclopramide"s beneficial effect in this indication appear to be a result of its antagonism of central and peripheral dopamine receptors,most notably by blocking stimulation of the medullary chemoreceptor trigger zone. No studies have yet evaluated the potential benefits of metoclopramide for the relief of AMS. In contrast, ibuprofen has been well studied and found to be an effective treatment for the relief of symptoms of high altitude headache and AMS.
The study will be a convenience sample of trekkers traveling through the Annapurna Circuit in Nepal during the 3 month time period of March-May, 2012. Subjects will be recruited from visitors to Manang, Nepal staying in local hostels, those visiting the Himalayan Rescue Association clinic in Manang, and those responding to locally posted signage regarding study enrollment.
Eligible patients will be consented and enrolled in the study. Patients will be randomized to receive either Ibuprofen 400mg or Metoclopramide 10mg by mouth. Investigators will be blinded as to which arm of the study the patient is enrolled. Participants will be assessed by Lake Louise Score and Visual Analog Scale for headache and nausea severity immediately prior to ingestion of study medication, and then serially at 30, 60, and 120 minutes following medication ingestion. Standard statistical analysis of the Lake Louise AMS scores and visual analog scales will be used to determine which medication is more effective in treating acute mountain sickness.
- Conditions
- Acute Mountain Sickness, High Altitude Headache
- Being tested
- Ibuprofen, Metoclopramide
- Keywords
- Acute Mountain Sickness, High Altitude Headache, Lake Louise AMS Score, Visual Analog Scale, Ibuprofen, Metoclopramide, Nepal
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Advil, Motrin
Ibuprofen 400mg tablet. Take one dose by mouth.
MetoclopramideDrug
Also called Reglan
Metoclopramide 10mg tablet. Take one tablet by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide | Experimental | 150 subjects with acute mountain sickness will be randomly assigned to take metoclopramide. Receives: Drug: Metoclopramide |
| Ibuprofen | Active comparator | 150 subjects with acute mountain sickness will be randomly assigned to take ibuprofen. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache and Nausea Visual Analog Scales
Subjects will complete 100mm visual analog scales of both headache and nausea at time zero, 30, 60, and 120 minutes after taking the study medication. Visual analog scales are a valid assessment of symptom severity for acute mountain sickness.
Measured: 120 minutes
Secondary outcomes (1)
Lake Louise Acute Mountain Sickness Score
Subjects will take the Lake Louise Acute Mountains Sickness score before taking the medication and 120 minutes after taking the medication. The Lake Louise Acute Mountain Sickness Score is a standard measure of the severity of acute mountain sickness and is commonly used in studies involving acute mountain sickness.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study start1 Mar 2012
- Primary completion1 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N. Stuart Harris MD MFA, Massachusetts General Hospital
- Investigators
- Norman S Harris, MD, MFA, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522326
- Sponsor's protocol ID
- 2010P002837
- Status last verified
- Sep 2020
- First submitted
- 27 Jan 2012
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Roach RC, Bartsch P, Hackett PH, Oelz O. The Lake Louise acute mountain sickness scoring system. Hypoxia and Molecular Medicine, J.R. Sutton, C. S. Huston, and G. Coates eds. Burlinton, VT, USA: Queen City Printers; 1993.
Gilbert DL. The first documented report of mountain sickness: the China or Headache Mountain story. Respir Physiol. 1983 Jun;52(3):315-26. doi: 10.1016/0034-5687(83)90088-9.
PubMed 6351209Gilbert DL. The first documented description of mountain sickness: the Andean or Pariacaca story. Respir Physiol. 1983 Jun;52(3):327-47. doi: 10.1016/0034-5687(83)90089-0.
PubMed 6351210Hultgren HN. High Altitude Pulmonary Edema. High Altitude Medicine. Stanford, CA: Hultgren Publications; 1997.
Montgomery AB, Mills J, Luce JM. Incidence of acute mountain sickness at intermediate altitude. JAMA. 1989 Feb 3;261(5):732-4.
PubMed 2911169Maggiorini M, Buhler B, Walter M, Oelz O. Prevalence of acute mountain sickness in the Swiss Alps. BMJ. 1990 Oct 13;301(6756):853-5. doi: 10.1136/bmj.301.6756.853.
PubMed 2282425Schneider M, Bernasch D, Weymann J, Holle R, Bartsch P. Acute mountain sickness: influence of susceptibility, preexposure, and ascent rate. Med Sci Sports Exerc. 2002 Dec;34(12):1886-91. doi: 10.1097/00005768-200212000-00005.
PubMed 12471292Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. doi: 10.1056/NEJM200107123450206. No abstract available.
PubMed 11450659Ellsworth AJ, Meyer EF, Larson EB. Acetazolamide or dexamethasone use versus placebo to prevent acute mountain sickness on Mount Rainier. West J Med. 1991 Mar;154(3):289-93.
PubMed 2028586Zell SC, Goodman PH. Acetazolamide and dexamethasone in the prevention of acute mountain sickness. West J Med. 1988 May;148(5):541-5.
PubMed 3051673Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. doi: 10.1016/s0140-6736(76)91677-9.
PubMed 62991Broome JR, Stoneham MD, Beeley JM, Milledge JS, Hughes AS. High altitude headache: treatment with ibuprofen. Aviat Space Environ Med. 1994 Jan;65(1):19-20.
PubMed 8117220Gertsch JH, Lipman GS, Holck PS, Merritt A, Mulcahy A, Fisher RS, Basnyat B, Allison E, Hanzelka K, Hazan A, Meyers Z, Odegaard J, Pook B, Thompson M, Slomovic B, Wahlberg H, Wilshaw V, Weiss EA, Zafren K. Prospective, double-blind, randomized, placebo-controlled comparison of acetazolamide versus ibuprofen for prophylaxis against high altitude headache: the Headache Evaluation at Altitude Trial (HEAT). Wilderness Environ Med. 2010 Sep;21(3):236-43. doi: 10.1016/j.wem.2010.06.009. Epub 2010 Jun 16.
PubMed 20832701Harris NS, Wenzel RP, Thomas SH. High altitude headache: efficacy of acetaminophen vs. ibuprofen in a randomized, controlled trial. J Emerg Med. 2003 May;24(4):383-7. doi: 10.1016/s0736-4679(03)00034-9.
PubMed 12745039Kirthi V, Derry S, Moore RA, McQuay HJ. Aspirin with or without an antiemetic for acute migraine headaches in adults. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD008041. doi: 10.1002/14651858.CD008041.pub2.
PubMed 20393963
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Mountain Sickness Treatment: A Double-blind Comparison of Metoclopramide vs. Ibuprofen
- ClinicalTrials.gov ID
- NCT01522326
- Acronym / sponsor ID
- 2010P002837
- Conditions
- Acute Mountain Sickness, High Altitude Headache
- Keywords
- Acute Mountain Sickness, High Altitude Headache, Lake Louise AMS Score, Visual Analog Scale, Ibuprofen, Metoclopramide, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2012
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the efficacy of metoclopramide in relieving the symptoms of Acute Mountain Sickness (AMS).
It is our hypothesis that the combined antiemetic and analgesic effects of metoclopramide (which has been study-proven to be effective in relieving symptoms of migraine headache) will prove to be more efficacious in relieving symptoms of acute mountain sickness than the standard, previously-studied analgesic medication, ibuprofen.
Detailed description
Acute Mountain Sickness (AMS) is a well described disease process that occurs as a result of rapid exposure to high altitude. High altitude headache (HAH) is defined as the presence of headache in the setting of a recent increase in altitude. When HAH is associated with nausea, vomiting, fatigue, weakness, dizziness, lightheadedness or poor sleeping, AMS is diagnosed. While benign, AMS is very common, afflicting up to 80 % of travelers who ascend rapidly to 14,000 ft, and can be debilitating. AMS is thought to occur secondary to hypoxia-induced cerebral vasodilation. The antiemetic metoclopramide has been well studied and is commonly administered for treatment of migraine headaches in emergency departments across the U.S. The symptoms of migraine headaches are often similar to those of AMS. The mechanism of metoclopramide"s beneficial effect in this indication appear to be a result of its antagonism of central and peripheral dopamine receptors,most notably by blocking stimulation of the medullary chemoreceptor trigger zone. No studies have yet evaluated the potential benefits of metoclopramide for the relief of AMS. In contrast, ibuprofen has been well studied and found to be an effective treatment for the relief of symptoms of high altitude headache and AMS.
The study will be a convenience sample of trekkers traveling through the Annapurna Circuit in Nepal during the 3 month time period of March-May, 2012. Subjects will be recruited from visitors to Manang, Nepal staying in local hostels, those visiting the Himalayan Rescue Association clinic in Manang, and those responding to locally posted signage regarding study enrollment.
Eligible patients will be consented and enrolled in the study. Patients will be randomized to receive either Ibuprofen 400mg or Metoclopramide 10mg by mouth. Investigators will be blinded as to which arm of the study the patient is enrolled. Participants will be assessed by Lake Louise Score and Visual Analog Scale for headache and nausea severity immediately prior to ingestion of study medication, and then serially at 30, 60, and 120 minutes following medication ingestion. Standard statistical analysis of the Lake Louise AMS scores and visual analog scales will be used to determine which medication is more effective in treating acute mountain sickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide | Experimental | Drug: Metoclopramide150 subjects with acute mountain sickness will be randomly assigned to take metoclopramide. |
| Ibuprofen | Active comparator | Drug: Ibuprofen150 subjects with acute mountain sickness will be randomly assigned to take ibuprofen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence at Manang recruitment center (at approximately 11,500 ft) during the dates March through May, 2012.
- Recent increase in altitude of > 1000 ft vertical in last 24 hours
- Presence of headache and at least one other symptom required for diagnosis of acute mountain sickness (including nausea, vomiting, fatigue, weakness, dizziness, lightheadedness or poor sleeping.)
Key exclusion criteria (7 listed)
- Age less than 19 years old
- Known allergy or contraindication to either ibuprofen or metoclopramide
- Evidence of severe high altitude illness (e.g. High altitude pulmonary edema (HAPE) as evidenced by dyspnea at rest -- or of High Altitude Cerebral Edema (HACE) as evidenced by altered mental status or ataxia)
- Known or suspected pregnancy
- Use of other analgesic or antiemetic within 8 hours of study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: Advil, MotrinIbuprofen 400mg tablet. Take one dose by mouth. | Drug | Ibuprofen |
| MetoclopramideAlso: ReglanMetoclopramide 10mg tablet. Take one tablet by mouth. | Drug | Metoclopramide |
Primary outcome
Headache and Nausea Visual Analog Scales
Time frame: 120 minutes
Subjects will complete 100mm visual analog scales of both headache and nausea at time zero, 30, 60, and 120 minutes after taking the study medication. Visual analog scales are a valid assessment of symptom severity for acute mountain sickness.
1 secondary outcome
Lake Louise Acute Mountain Sickness Score
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- BackgroundRoach RC, Bartsch P, Hackett PH, Oelz O. The Lake Louise acute mountain sickness scoring system. Hypoxia and Molecular Medicine, J.R. Sutton, C. S. Huston, and G. Coates eds. Burlinton, VT, USA: Queen City Printers; 1993.
- Background: PubMed 6351209Gilbert DL. The first documented report of mountain sickness: the China or Headache Mountain story. Respir Physiol. 1983 Jun;52(3):315-26. doi: 10.1016/0034-5687(83)90088-9.
- Background: PubMed 6351210Gilbert DL. The first documented description of mountain sickness: the Andean or Pariacaca story. Respir Physiol. 1983 Jun;52(3):327-47. doi: 10.1016/0034-5687(83)90089-0.
- BackgroundHultgren HN. High Altitude Pulmonary Edema. High Altitude Medicine. Stanford, CA: Hultgren Publications; 1997.
- Background: PubMed 2911169Montgomery AB, Mills J, Luce JM. Incidence of acute mountain sickness at intermediate altitude. JAMA. 1989 Feb 3;261(5):732-4.
- Background: PubMed 2282425Maggiorini M, Buhler B, Walter M, Oelz O. Prevalence of acute mountain sickness in the Swiss Alps. BMJ. 1990 Oct 13;301(6756):853-5. doi: 10.1136/bmj.301.6756.853.
- Background: PubMed 12471292Schneider M, Bernasch D, Weymann J, Holle R, Bartsch P. Acute mountain sickness: influence of susceptibility, preexposure, and ascent rate. Med Sci Sports Exerc. 2002 Dec;34(12):1886-91. doi: 10.1097/00005768-200212000-00005.
- Background: PubMed 11450659Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. doi: 10.1056/NEJM200107123450206. No abstract available.
- Background: PubMed 2028586Ellsworth AJ, Meyer EF, Larson EB. Acetazolamide or dexamethasone use versus placebo to prevent acute mountain sickness on Mount Rainier. West J Med. 1991 Mar;154(3):289-93.
- Background: PubMed 3051673Zell SC, Goodman PH. Acetazolamide and dexamethasone in the prevention of acute mountain sickness. West J Med. 1988 May;148(5):541-5.
- Background: PubMed 62991Hackett PH, Rennie D, Levine HD. The incidence, importance, and prophylaxis of acute mountain sickness. Lancet. 1976 Nov 27;2(7996):1149-55. doi: 10.1016/s0140-6736(76)91677-9.
- Background: PubMed 8117220Broome JR, Stoneham MD, Beeley JM, Milledge JS, Hughes AS. High altitude headache: treatment with ibuprofen. Aviat Space Environ Med. 1994 Jan;65(1):19-20.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman S Harris, MD, MFA principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Metoclopramide in people with Acute Mountain Sickness and High Altitude Headache, run by Massachusetts General Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache and Nausea Visual Analog Scales (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522326, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.