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

NCT02000401 | Completed Phase 4

• 1 other identifier: 0703-2012-SPRIX
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the Visual Analog Scale

  5 days

Secondary Outcomes (1)

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

  5 days

Study Arms (1)

Ketorolac Tromethamine

OTHER

Ketorolac 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.

Drug: Ketorolac Tromethamine

Interventions

Ketorolac Tromethamine DRUG

Also known as: SPRIX

Ketorolac Tromethamine

Eligibility Criteria

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

You may qualify if:

• 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
• 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

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) 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
• 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

Sponsors & Collaborators

• Citrus Valley Medical Research, Inc.: lead

Study Sites (1)

Citrus Valley Medical Research, Inc

Glendora, California, 91741, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Edward L Davis, M.D.

  Citrus Valley Medical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2013-11

Locations

US (1)