IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

February 1, 2016 updated by: Emily Rubenstein Engel, Scripps Health

IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (Cambia) for the Acute Treatment of Severe Migraine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The treatment of severe migraine often requires a patient office visit or treatment in the ER or urgent care setting. This is due to the minimal efficacy of PO treatments once migraine is severe, and therefore the need for parenteral treatments. IM Ketorolac is one mainstay of parenteral treatment. There is an unmet need for effective at-home treatment regimens for severe migraine. Despite FDA approval of Cambia for acute migraine treatment, insurance is reticent to cover the treatment due to higher cost in comparison to generic diclofenac tablets, despite superior efficacy of Cambia in comparison to generic diclofenac tablets (Diener, Cephalalgia 2006). One objective of this study would be to provide rationale to justify the insurance coverage of this treatment in comparison to generic tablets, because at home treatment is less costly than office visit or emergency department visit to receive IM ketorolac.

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)

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cambia
Diclofenac postassium powder for oral solution and placebo injection
Drug: 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
Other Names:
  • Cambia
Active Comparator: ketorolac
ketorolac intramuscular injection and placebo oral solution
Drug: 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 Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain relief, 0-3 scale
Time Frame: Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention
Change from baseline pain rating at 5, 10, 15, 30, and 60 minutes post intervention
Pain free response, 0-3 scale
Time Frame: 2 hours post intervention
2 hours post intervention
Sustained pain free response, 0-3 scale
Time Frame: 24 hours post intervention
24 hours post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in severity of migraine associated symptoms
Time Frame: 5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention
Disability, Nausea, Photophonia/phonophobia self reported using a 0-3 rating scale
5, 10, 15, 30, 60, 120 minutes and 24 hours post intervention
Return to function
Time Frame: 24 hours post intervention
Severity, Disability, Nausea, Photophonia/phonophobia self reported as 0 on 0-3 scale
24 hours post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Collaborators

Depomed

Investigators

  • Principal Investigator: Emily Rubenstein Engel, MD, Scripps Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

January 18, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Estimate)

February 3, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual Patient Data will not be made available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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