IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine
NCT ID: NCT02664116
Last Updated: 2016-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2016-01-31
2017-07-31
Brief Summary
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Detailed Description
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A previous study of Cambia demonstrated that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment (Lipton, Cephalalgia 2010)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cambia
Diclofenac postassium powder for oral solution and placebo injection
Diclofenac postassium powder for oral solution and placebo injection
Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose
ketorolac
ketorolac intramuscular injection and placebo oral solution
Ketorolac intramuscular injection and placebo oral solution
ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose
Interventions
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Diclofenac postassium powder for oral solution and placebo injection
Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose
Ketorolac intramuscular injection and placebo oral solution
ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 to 65
* At least 2 migraine attacks per month
* Able to give written consent
* Willing to complete the entire course of the study
* Current headache duration greater than or equal to 36 hours
Exclusion Criteria
* Significant medical or psychiatric disease
* History of gastritis, gastric ulcer, GI bleed
* Renal insufficiency
* Hepatic insufficiency
* History of opioid dependence within the last 10 years or currently
* Any current or prior use of DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION (CAMBIA)
* Past allergic reaction to DICLOFENAC or other NSAIDs
18 Years
65 Years
ALL
No
Sponsors
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Depomed
INDUSTRY
Scripps Health
OTHER
Responsible Party
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Emily Rubenstein Engel
Associate Director, Dalessio Headache Center, Scripps Clinic
Principal Investigators
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Emily Rubenstein Engel, MD
Role: PRINCIPAL_INVESTIGATOR
Scripps Health
Locations
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Scripps Clinic
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Factor SA, Jankovic J. Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine. Neurology. 2014 Oct 7;83(15):1388-9. doi: 10.1212/01.wnl.0000455698.16732.0a. No abstract available.
Garnock-Jones KP. Diclofenac potassium powder for oral solution: a review of its use in patients with acute migraine. CNS Drugs. 2014 Aug;28(8):761-8. doi: 10.1007/s40263-014-0186-y.
Friedman BW, Garber L, Yoon A, Solorzano C, Wollowitz A, Esses D, Bijur PE, Gallagher EJ. Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine. Neurology. 2014 Mar 18;82(11):976-83. doi: 10.1212/WNL.0000000000000223. Epub 2014 Feb 12.
Taggart E, Doran S, Kokotillo A, Campbell S, Villa-Roel C, Rowe BH. Ketorolac in the treatment of acute migraine: a systematic review. Headache. 2013 Feb;53(2):277-87. doi: 10.1111/head.12009. Epub 2013 Jan 8.
Lipton RB, Grosberg B, Singer RP, Pearlman SH, Sorrentino JV, Quiring JN, Saper JR. Efficacy and tolerability of a new powdered formulation of diclofenac potassium for oral solution for the acute treatment of migraine: results from the International Migraine Pain Assessment Clinical Trial (IMPACT). Cephalalgia. 2010 Nov;30(11):1336-45. doi: 10.1177/0333102410367523. Epub 2010 Apr 7.
Duarte C, Dunaway F, Turner L, Aldag J, Frederick R. Ketorolac versus meperidine and hydroxyzine in the treatment of acute migraine headache: a randomized, prospective, double-blind trial. Ann Emerg Med. 1992 Sep;21(9):1116-21. doi: 10.1016/s0196-0644(05)80654-7.
Orr SL, Aube M, Becker WJ, Davenport WJ, Dilli E, Dodick D, Giammarco R, Gladstone J, Leroux E, Pim H, Dickinson G, Christie SN. Canadian Headache Society systematic review and recommendations on the treatment of migraine pain in emergency settings. Cephalalgia. 2015 Mar;35(3):271-84. doi: 10.1177/0333102414535997. Epub 2014 May 29.
Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.
Diener HC, Montagna P, Gacs G, Lyczak P, Schumann G, Zoller B, Mulder LJ, Siegel J, Edson K. Efficacy and tolerability of diclofenac potassium sachets in migraine: a randomized, double-blind, cross-over study in comparison with diclofenac potassium tablets and placebo. Cephalalgia. 2006 May;26(5):537-47. doi: 10.1111/j.1468-2982.2005.01064.x.
Engel ER, Cheng J. IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial. Neurol Sci. 2020 Mar;41(3):537-542. doi: 10.1007/s10072-019-04157-y. Epub 2019 Dec 12.
Other Identifiers
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DHC-002
Identifier Type: -
Identifier Source: org_study_id
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