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Interstitial CystitisPhase 4NCT02000401

Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain

A Phase 4 study testing Ketorolac Tromethamine in people with Interstitial Cystitis, run by Citrus Valley Medical Research, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intranasal Ketorolac tromethamine has a potential role as a short term pain management tool for Interstitial Cystitis without the risk and undesirable effects of narcotics. Read more about this study

Who is it for?
Ages 18 to 64 years, women only
Conditions the study is for
Interstitial Cystitis
What is being tested?
Ketorolac Tromethamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
May 2012to Jul 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 18 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female Subject must be between the age eighteen (18) years and sixty four (64)
  • Subject must weigh 110lbs (50kg) or greater
  • Willing and able to provide an informed consent
  • Diagnosed with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
  • Symptoms of IC/PBS that are moderate to severe (intermittent or chronic) for ≥ three (3) months
  • A cystoscopic examination under anesthesia with hydro-distention and photo documentation will have been performed at time of diagnosis with IC. Bladder biopsies will have been performed only if carcinoma is suspected. (see exclusion # 5.2.25 - hydrodistention must be performed greater than four (4) weeks prior to baseline visit) Note: at investigator discretion subject may included with only operative report
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  • At screening subject must have a score ≥ four (4) out of ten (10) On Visual Analogue Pain Scale (VAS Pain Scale)
  • Subject must have a score on the O'Leary/Sant scale of at least a five (5) on the symptom index at screening
  • Voids greater than eight (8) in a twenty four (24) hour period
  • Nocturia of at least one (1) time during sleeping period
  • Subject of child-bearing potential must test negative for pregnancy prior to treatment or provide documentation for having undergone the following: hysterectomy or tubal ligation. Subjects who are physiologically capable of becoming pregnant must voluntarily sign a pregnancy waiver included within the informed consent and agree not to become pregnant for the duration of the study and for thirty (30) days following the completion of study. If a subject becomes pregnant during the course of this study, the subject will inform the Principal Investigator within one (1) working day of learning of the pregnancy

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) NOTE: if at time of signing consent a subject is receiving a non-steroidal inflammatory drug they may washout for seven days prior to completing the screening visit
  • Subject is currently receiving or having had prior IC/PBS focused therapy on less than three (3) months stable doses. i.e. oral Pentosan Polysulfate(PPS) (Elmiron®), Amitriptyline (Elavil®), oxychlorosene (Clorpactin®), dimethyl sulfoxide (RIMSO 50™), heparin or antihistamine NOTE: Antihistamine is allowable as added treatment during course of study if for treatment of diagnosed nasal/seasonal/environmental allergy (i.e treatment other than IC) , If a subject is receiving intravesical instillations of any kind at least a two day washout must be adhered to before screening is performed. The subject must abstain from any intravesical instillation during the study.
  • Current use of TENS (Transcutaneous Electrical Nerve Stimulation) or Interstim unit
  • Clinically significant urinary tract infection (UTI) NOTE: dipstick urinalysis is done at screening urine culture will be performed if indicated by results of dipstick urinalysis at screening
  • As needed Use of narcotics/opiate within one (1) week prior to the screening visit and entire study participation by self-reporting (Note: once subject has qualified they will be given the option of rescue medication for pain not relieved by the study medication)
  • Use of illegal drugs by self-reporting
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  • History of drug or alcohol abuse within five (5) years of screening visit
  • History of suicide attempt or suicidal thoughts by self-reporting within five (5) years of screening visit
  • Any active co-morbid pelvic diagnosis (i.e. endometriosis, Irritable Bowel Syndrome, etc.) for which the subject is unable to distinguish between IC/PBS pain and pain from any other condition as determined by the investigator
  • A diagnosis of a severe neuro-psychiatric disease
  • Subject demonstrates an absence of nocturia
  • Subject's frequency of urination is equal to or less than eight (8) times in a twenty four (24) hour period.
  • Subject's symptoms relieved by antimicrobials, urinary antiseptics, anticholinergics, or antispasmodics.
  • Subject has recurrent bladder or lower urethral calculi (recurrent is defined as > to 3 times in a 12 month period)
  • Subject has active genital herpes with a (3) three month period of the screening visit
  • Subject has uterine, cervical, vaginal, or urethral cancer
  • Subject has been administered cyclophosphamide or any agent that causes chemical cystitis
  • Subject has tubercular cystitis
  • Subject has radiation cystitis
  • Subject has benign or malignant bladder tumor
  • Subject has a positive pathologic vaginal culture within three (3) months of the screening visit
  • Subject has evidence of vesicle ureteral reflux or urethral diverticula
  • Subject has neurogenic bladder dysfunction
  • Subject has a prior urinary diversion
  • 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 who is pregnant or lactating
  • Subject with history of hydro-distention within four (4) weeks of baseline visit
  • Subject with history of clinically significant cardiovascular disease such as: (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.
  • Subject over sixty four (64) years of age
  • Subject who weighs less than 110lbs (50kg)
  • Subject with history of any clinically significant blood chemistry, renal function or liver abnormality defined as + two (2X) normal values
  • Subject who has history of a bleeding problem or low platelet count
  • 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 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Citrus Valley Medical Research, Inc

    Glendora, California, 91741

Other trials in United States

About this study

Official title: To Evaluate the Efficacy, Tolerability, and Safety of Intranasal Ketorolac Tromethamine (Sprix) as an Option for Acute (up to 5 Days) Pain Management Adult Interstitial Cystitis Patients Experiencing a Flare of Pain

Intranasal Ketorolac tromethamine has a potential role as a short term pain management tool for Interstitial Cystitis without the risk and undesirable effects of narcotics.

Being tested
Ketorolac Tromethamine
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketorolac TromethamineDrug

    Also called SPRIX

Study groups in NCT02000401
Study groupRoleWhat they receive
Ketorolac TromethamineOtherKetorolac Tromethamine 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 pain with a maximum daily dose of 126 mg. The treatment may be continued for up to 5 days.
Receives: Drug: Ketorolac Tromethamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Scores on the Visual Analog Scale

    Measured: 5 days

Secondary outcomes (1)

  1. 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.

  1. First posted4 Dec 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02000401
Sponsor's protocol ID
0703-2012-SPRIX
Status last verified
Nov 2013
First submitted
19 Nov 2013
Last updated
4 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac Tromethamine in people with Interstitial Cystitis, run by Citrus Valley Medical Research, Inc. at 1 site in United States.

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 11 inclusion and 40 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: finished, 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.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

On the ClinicalTrials.gov record for NCT02000401.

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.

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