NCT02664116

Brief Summary

This research will be conducted to see if the oral drug Cambia is as effective in relieving severe migraine headaches as the injectable drug ketorolac.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

January 18, 2016

Last Update Submit

February 1, 2016

Conditions

Migraine Headache

Keywords

Severe Migraine Headache

Outcome Measures

Primary Outcomes (3)

  • Pain relief, 0-3 scale

    Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention

  • Pain free response, 0-3 scale

    2 hours post intervention

  • Sustained pain free response, 0-3 scale

    24 hours post intervention

Secondary Outcomes (2)

  • Change in severity of migraine associated symptoms

    5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention

  • Return to function

    24 hours post intervention

Study Arms (2)

Cambia

EXPERIMENTAL

Diclofenac postassium powder for oral solution and placebo injection

Drug: Diclofenac postassium powder for oral solution and placebo injection

ketorolac

ACTIVE COMPARATOR

ketorolac intramuscular injection and placebo oral solution

Drug: Ketorolac intramuscular injection and placebo oral solution

Interventions

Diclofenac postassium powder for oral solution and placebo injectionDRUG

Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose

Also known as: Cambia
Cambia
Ketorolac intramuscular injection and placebo oral solutionDRUG

ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose

Also known as: Toradol
ketorolac

Eligibility Criteria

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

You may qualify if:

  • Patients who meet IHS criteria for migraine
  • 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

You may not qualify if:

  • Pregnant or nursing
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Clinic

La Jolla, California, 92037, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 25288700BACKGROUND

  • 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.

    PMID: 25034250BACKGROUND

  • 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.

    PMID: 24523483BACKGROUND

  • 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.

    PMID: 23298250BACKGROUND

  • 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.

    PMID: 20959428BACKGROUND

  • 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.

    PMID: 1514724BACKGROUND

  • 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.

    PMID: 24875925BACKGROUND

  • 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.

    PMID: 25600718BACKGROUND

  • 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.

    PMID: 16674762BACKGROUND

  • 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.

    PMID: 31833000DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

SolutionsDiclofenacKetorolac Tromethamine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Emily Rubenstein Engel, MD

    Scripps Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Rubenstein Engel, MD

CONTACT

858-554-8887Engel.EmilyRubenstein@scrippshealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Dalessio Headache Center, Scripps Clinic

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 26, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Individual Patient Data will not be made available

Locations

US(1)