Trial record 3 of 5 for:    vasectomy

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Citrus Valley Medical Research, Inc.
ClinicalTrials.gov Identifier:
NCT02000388
First received: November 19, 2013
Last updated: December 3, 2013
Last verified: November 2013
  Purpose

To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine (SPRIX) as an option for pain management in post vasectomy patients.


Condition Intervention Phase
Post Vasectomy Pain
Drug: Ketorolac Tromethamine
Other: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Citrus Valley Medical Research, Inc.:

Primary Outcome Measures:
  • Pain Scores on the Visual Analog Scale [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ketorolac Tromethamine
Other Name: SPRIX
Standard of care
The intervention used will be standard of care
Other: Standard of Care
Other Name: Standard of Care

  Eligibility

Ages Eligible for Study:   25 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000388

Sponsors and Collaborators
Citrus Valley Medical Research, Inc.
Investigators
Principal Investigator: Edward L Davis, M.D. Citrus Valley Medical Research, Inc.
  More Information

No publications provided

Responsible Party: Citrus Valley Medical Research, Inc.
ClinicalTrials.gov Identifier: NCT02000388     History of Changes
Other Study ID Numbers: 1012-2011-SPRIX
Study First Received: November 19, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ketorolac Tromethamine
Ketorolac
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014