Post Vasectomy PainPhase 4NCT02000388
Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
A Phase 4 study testing Ketorolac Tromethamine in people with Post Vasectomy Pain, run by Citrus Valley Medical Research, Inc..
Trial summary
To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine (SPRIX) as an option for pain management in post vasectomy patients. Read more about this study
- Who is it for?
- Ages 25 to 64 years, men only
- Conditions the study is for
- Post Vasectomy Pain
- What is being tested?
- Ketorolac Tromethamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Major surgery scheduled within 3 weeks or screening and for entire participation of study
- Current exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis
- Any condition in the opinion of the investigator that makes the subject unsuitable for study
- -
About this study
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
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
- Being tested
- Ketorolac Tromethamine, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called SPRIX
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ketorolac Tromethamine |
| Standard of care | Other | The intervention used will be standard of care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
Measured: 5 days
Secondary outcomes (1)
To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Vasectomy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Citrus Valley Medical Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward L Davis, M.D., Principal investigator, Citrus Valley Medical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000388
- Sponsor's protocol ID
- 1012-2011-SPRIX
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02000388
- Acronym / sponsor ID
- 1012-2011-SPRIX
- Conditions
- Post Vasectomy Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Citrus Valley Medical Research, Inc.University, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy, tolerability and safety of intranasal ketorolac tromethamine (SPRIX) as an option for pain management in post vasectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac tromethamine (SPRIX) | Other | Drug: Ketorolac TromethamineA 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. |
| Standard of care | Other | Other: Standard of CareThe intervention used will be standard of care |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineAlso: SPRIX | Drug | Ketorolac tromethamine (SPRIX) |
| Standard of Care | Other | Standard of care |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: 5 days
1 secondary outcome
To determine Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 5 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
Related trials for Post Vasectomy Pain
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Post-Vasectomy Pain Study
Vasectomy, NSAIDs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward L Davis, M.D. principal investigator
Citrus Valley Medical Research, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac Tromethamine in people with Post Vasectomy Pain, run by Citrus Valley Medical Research, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Visual Analog Scale (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013.