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Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain

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ClinicalTrials.gov Identifier: NCT02000388
Recruitment Status : Unknown
Verified November 2013 by Citrus Valley Medical Research, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Citrus Valley Medical Research, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE December 4, 2013
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
Pain Scores on the Visual Analog Scale [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
Official Title  ICMJE Efficacy and Safety of Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management Tool for Adult Male Patients With Post-Vasectomy Pain
Brief Summary To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine (SPRIX) as an option for pain management in post vasectomy patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Vasectomy Pain
Intervention  ICMJE
  • Drug: Ketorolac Tromethamine
    Other Name: SPRIX
  • Other: Standard of Care
Study Arms  ICMJE
  • Ketorolac tromethamine (SPRIX)
    A SPRIX dose will be one 15.75 mg spray in each nostril for a total dose of 31.5 mg which can be repeated every 6-8 hrs as needed for post vasectomy pain with a maximum daily dose of 126 mg to be continued for up to 5 days.
    Intervention: Drug: Ketorolac Tromethamine
  • Standard of care
    The intervention used will be standard of care
    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000388
Other Study ID Numbers  ICMJE 1012-2011-SPRIX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Citrus Valley Medical Research, Inc.
Study Sponsor  ICMJE Citrus Valley Medical Research, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward L Davis, M.D. Citrus Valley Medical Research, Inc.
PRS Account Citrus Valley Medical Research, Inc.
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP