Recruiting

Ketorolac vs. Cambia

Sponsor:

Scripps Health

Code:

NCT02664116

Conditions

Migraine Headache

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Diclofenac postassium powder for oral solution and placebo injection

Ketorolac intramuscular injection and placebo oral solution

Study Details

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.

Conditions

Migraine Headache

Study ID

NCT02664116

Start date

Jan, 2016

Status verified date

Feb, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cambia

Diclofenac postassium powder for oral solution and placebo injection

active comparator: ketorolac

ketorolac intramuscular injection and placebo oral solution

Interventions

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

Primary outcome measure

  • Pain relief, 0-3 scale [ Time Frame: 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 ]
  • Sustained pain free response, 0-3 scale [ Time Frame: 24 hours post intervention ]

Central Contacts and Locations

Central contacts

Emily Rubenstein Engel, MD

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

Locations

Scripps Clinic

Recruiting

La Jolla, California, United States, 92037

Contacts

Emily Rubenstein Engel, M.D.

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

More Information

Sponsor

Scripps Health

Last update posted

Feb 3, 2016

Last verified

Feb, 2016

Keywords

  • Severe Migraine Headache

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Health on 2016-02-03.