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Clinical Trials/EUCTR2007-001431-58-DE
EUCTR2007-001431-58-DEActive, not recruitingNot Applicable

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine - ROX-2007-01

ROXRO PHARMA, Inc.0 sites140 target enrollmentStarted: April 23, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
140
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Female and male subjects aged 18 to 65 years.
  • •2. Diagnosis of migraine with or without aura according to IHS criteria 1.1 and 1.2.1.
  • •3. Onset of migraine prior to age 50 years.
  • •4. Subjects who have between 2 and 8 moderate or severe migraine headaches per month.
  • •5. Ability to communicate well with the study staff and to comply with the requirements of the entire study.
  • •6. Subjects who read and understood the patient information sheet and have provided written informed consent to participate in this study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Administration of any investigational drug up to 30 days before study entry or parallel participation in another study.
  • •2. Subjects with more than 15 headache days per month.
  • •3. Subjects with known allergy to, or known hypersensitivity to ketorolac, lidocaine, EDTA, or tromethamine.
  • •4. Subjects with allergic manifestations to aspirin or other NSAIDs or with known history of sensitivity to local anesthetics of the amide type.
  • •5. Patients currently receiving aspirin or NSAIDs.
  • •6. Subjects who have at screening, as determined by the investigator, abnormal laboratory parameters in particular, liver or renal functions tests greater than twice the upper limit of normal.
  • •7. Subjects with advance renal impairment or patients at risk for renal failure due to volume depletion.
  • •8. Subjects with a history of a significant medical or psychiatric condition that may affect the safety of the subject or preclude adequate participation in the study.
  • •9. Subjects with active peptic ulcer disease or a significant history of peptic ulcer disease or gastrointestinal bleeding.
  • •10. Subjects with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and high risk of bleeding.
  • •11. Subjects with a history within the last 2 years of abuse of alcohol or prescription or illicit drugs.
  • •12. Subjects with any history of cocaine use.
  • •13. Subjects who have ever used opiates regularly for any indication and any opiate use in the last 3 months.
  • •14. Subjects who are pregnant or breast-feeding. Female subjects who are of child bearing potential must be using highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives in combination with a barrier method, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner).
  • •15. Subjects using migraine prophylaxis must have been on stable doses of the prophylactic agent for at least 12 weeks prior to study entry.
  • •16. Known Hepatitis B or C or HIV infection.
  • •17. Subjects who are employees of the sponsor.
  • •18. Subjects who are employees or relatives of the investigator.
  • •19. Subjects with bronchial asthma.

Investigators

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