Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
Information source: Citrus Valley Medical Research, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Vasectomy Pain
Intervention: Ketorolac Tromethamine (Drug); Standard of Care (Other)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Citrus Valley Medical Research, Inc. Official(s) and/or principal investigator(s): Edward L Davis, M.D., Principal Investigator, Affiliation: Citrus Valley Medical Research, Inc.
Summary
To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine
(SPRIX) as an option for pain management in post vasectomy patients.
Clinical Details
Official title: Efficacy and Safety of Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management Tool for Adult Male Patients With Post-Vasectomy Pain
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pain Scores on the Visual Analog Scale
Secondary outcome: To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Eligibility
Minimum age: 25 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
INCLUSION CRITERIA
1. Male Subject must be between the age twenty five (25) years and sixty four (64)
2. Willing and able to provide an informed consent
3. Has made decision to undergo vasectomy
4. Subject is in good general physical condition as assessed by the Principal
Investigator
EXCLUSION CRITERIA
1. Current treatment with or known allergy or sensitivity to all forms of ketorolac
tromethamine , aspirin , other non steroidal anti inflammatory drugs (NSAIDs) or
Ethylenediaminetetraacetic acid (EDTA)
2. Use of narcotics/opiate or medical marijuana within one (1) week prior to the
baseline visit and entire study participation
3. Use of illegal drugs by self reporting
4. History of drug or alcohol abuse within five (5) years of screening visit
5. History of suicide attempt within five (5) years of screening visit
6. A diagnosis of a severe neuro-psychiatric disease
7. Subject who is currently receiving investigational drug(s) or participated in a
clinical trial involving investigational drug(s) within thirty (30) day of the
screening visit
8. Subject with history of any of the following coronary conditions: (chronic stable
angina being currently treated with long acting nitrates, chronic stable angina
require treatment with short acting nitrates with 90 days of visit 1, angina
occurring during sexual intercourse in the last six months, unstable angina within
six months of visit 1
9. Resting, sitting blood pressure (BP) > 160mm Hg in systolic pressure or > 100mm Hg is
diastolic pressure at screening. If a patient is found to have untreated significant
hypertension at screening and antihypertensive treatment is initiated, assessment for
study eligibility should be deferred until BP and antihypertensive medication have
been stable for at least one month. For patients with previously diagnosed
hypertension, antihypertensive medications must be stable for at least one month
prior to screening.
10. Known or suspected cerebrovascular bleeding, hemorrhagic diathesis or incomplete
hemostasis, and those at high risk of bleeding, have history of a bleeding problem or
low platelet count or coagulation disorder or are on therapy that affects homeostasis
11. Active peptic ulcer disease, recent GI bleeding or perforation, or a history of
peptic ulcers or GI bleeding
12. History of asthma, urticaria or other allergic-type reaction after taking aspirin or
other non steroidal inflammatory drugs (NASIDs)
13. Subject over sixty four (64) years of age
14. Subject with any clinically significant renal function or liver abnormality
15. Subject who has history of swelling of face, mouth, tongue, lips, gums, neck, or
throat (angioedema) or with cardiac decompensation or similar conditions
16. Major surgery scheduled within 3 weeks or screening and for entire participation of
study
17. Current exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal
necrolysis
18. Any condition in the opinion of the investigator that makes the subject unsuitable
for study
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Locations and Contacts
Additional Information
Starting date: February 2012
Last updated: December 3, 2013
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