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

NCT02000388 | Unknown Phase 4

• 1 other identifier: 1012-2011-SPRIX
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post Vasectomy Pain

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Visual Analog Scale

  5 days

Secondary Outcomes (1)

• To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  5 Days

Study Arms (2)

Ketorolac tromethamine (SPRIX)

OTHER

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

Standard of care

OTHER

The intervention used will be standard of care

Other: Standard of Care

Interventions

Ketorolac Tromethamine DRUG

Also known as: SPRIX

Ketorolac tromethamine (SPRIX)

Standard of Care OTHER

Standard of care

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male Subject must be between the age twenty five (25) years and sixty four (64)
• Willing and able to provide an informed consent
• Has made decision to undergo vasectomy
• Subject is in good general physical condition as assessed by the Principal Investigator

You may not qualify if:

• 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)
• Use of narcotics/opiate or medical marijuana within one (1) week prior to the baseline visit and entire study participation
• Use of illegal drugs by self reporting
• History of drug or alcohol abuse within five (5) years of screening visit
• History of suicide attempt within five (5) years of screening visit
• A diagnosis of a severe neuro-psychiatric disease
• 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
• 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
• 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.
• 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
• Active peptic ulcer disease, recent GI bleeding or perforation, or a history of peptic ulcers or GI bleeding
• History of asthma, urticaria or other allergic-type reaction after taking aspirin or other non steroidal inflammatory drugs (NASIDs)
• Subject over sixty four (64) years of age
• Subject with any clinically significant renal function or liver abnormality
• Subject who has history of swelling of face, mouth, tongue, lips, gums, neck, or throat (angioedema) or with cardiac decompensation or similar conditions

Sponsors & Collaborators

• Citrus Valley Medical Research, Inc.: lead

MeSH Terms

Interventions

Ketorolac Tromethamine; Standard of Care

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Edward L Davis, M.D.

  Citrus Valley Medical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 4, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-11