NCT01522326

Brief 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 prove to be more efficacious in relieving symptoms of acute mountain sickness than the standard, previously-studied analgesic medication, ibuprofen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

5 years

First QC Date

January 27, 2012

Last Update Submit

September 1, 2020

Conditions

Acute Mountain SicknessHigh Altitude Headache

Keywords

Acute Mountain SicknessHigh Altitude HeadacheLake Louise AMS ScoreVisual Analog ScaleIbuprofenMetoclopramideNepal

Outcome Measures

Primary Outcomes (1)

  • 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.

    120 minutes

Secondary Outcomes (1)

  • Lake Louise Acute Mountain Sickness Score

    120 minutes

Study Arms (2)

Metoclopramide

EXPERIMENTAL

150 subjects with acute mountain sickness will be randomly assigned to take metoclopramide.

Drug: Metoclopramide

Ibuprofen

ACTIVE COMPARATOR

150 subjects with acute mountain sickness will be randomly assigned to take ibuprofen.

Drug: Ibuprofen

Interventions

IbuprofenDRUG

Ibuprofen 400mg tablet. Take one dose by mouth.

Also known as: Advil, Motrin
Ibuprofen
MetoclopramideDRUG

Metoclopramide 10mg tablet. Take one tablet by mouth.

Also known as: Reglan
Metoclopramide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manang Clinic of the Himalayan Rescue Association

Manang, District of Manang, 33500, Nepal

Location

Related Publications (20)

  • 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.

    BACKGROUND

  • 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.

    PMID: 6351209BACKGROUND

  • Gilbert 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.

    PMID: 6351210BACKGROUND

  • Hultgren HN. High Altitude Pulmonary Edema. High Altitude Medicine. Stanford, CA: Hultgren Publications; 1997.

    BACKGROUND

  • Montgomery AB, Mills J, Luce JM. Incidence of acute mountain sickness at intermediate altitude. JAMA. 1989 Feb 3;261(5):732-4.

    PMID: 2911169BACKGROUND

  • Maggiorini 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.

    PMID: 2282425BACKGROUND

  • Schneider 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.

    PMID: 12471292BACKGROUND

  • Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. doi: 10.1056/NEJM200107123450206. No abstract available.

    PMID: 11450659BACKGROUND

  • Ellsworth 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.

    PMID: 2028586BACKGROUND

  • Zell SC, Goodman PH. Acetazolamide and dexamethasone in the prevention of acute mountain sickness. West J Med. 1988 May;148(5):541-5.

    PMID: 3051673BACKGROUND

  • Hackett 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.

    PMID: 62991BACKGROUND

  • Broome 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.

    PMID: 8117220BACKGROUND

  • Gertsch 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.

    PMID: 20832701BACKGROUND

  • Harris 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.

    PMID: 12745039BACKGROUND

  • Kirthi 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.

    PMID: 20393963BACKGROUND

  • Griffith JD, Mycyk MB, Kyriacou DN. Metoclopramide versus hydromorphone for the emergency department treatment of migraine headache. J Pain. 2008 Jan;9(1):88-94. doi: 10.1016/j.jpain.2007.09.001. Epub 2007 Nov 5.

    PMID: 17981511BACKGROUND

  • Friedman BW, Corbo J, Lipton RB, Bijur PE, Esses D, Solorzano C, Gallagher EJ. A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines. Neurology. 2005 Feb 8;64(3):463-8. doi: 10.1212/01.WNL.0000150904.28131.DD.

    PMID: 15699376BACKGROUND

  • Colman I, Brown MD, Innes GD, Grafstein E, Roberts TE, Rowe BH. Parenteral metoclopramide for acute migraine: meta-analysis of randomised controlled trials. BMJ. 2004 Dec 11;329(7479):1369-73. doi: 10.1136/bmj.38281.595718.7C. Epub 2004 Nov 18.

    PMID: 15550401BACKGROUND

  • The Lake Louise Consensus on the Definition and Quantification of Altitude Illness. In: Sutton J, Coates G, Houston C, eds. Hypoxia and Molecular Medicine. Burlington, VT: Queen City Printers; 1993.

    BACKGROUND

  • Kayser B, Aliverti A, Pellegrino R, Dellaca R, Quaranta M, Pompilio P, Miserocchi G, Cogo A. Comparison of a visual analogue scale and Lake Louise symptom scores for acute mountain sickness. High Alt Med Biol. 2010 Spring;11(1):69-72. doi: 10.1089/ham.2009.1046.

    PMID: 20367491BACKGROUND

MeSH Terms

Conditions

Altitude Sickness

Interventions

IbuprofenMetoclopramide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzamidesAmidespara-AminobenzoatesAminobenzoatesBenzoatesChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Norman S Harris, MD, MFA

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, MGH Wilderness Medicine Fellowship; Chief, Division of Wilderness Medicine, Department of Emergency Medicine, Massachusetts General Hospital; Assistant Professor of Surgery, Harvard Medical School

Study Record Dates

First Submitted

January 27, 2012

First Posted

January 31, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 30, 2017

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

NE(1)