World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02000401
Date of registration: 19/11/2013
Prospective Registration: No
Primary sponsor: Citrus Valley Medical Research, Inc.
Public title: Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
Scientific 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
Date of first enrolment: May 2012
Target sample size: 15
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02000401
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Edward L Davis, M.D.
Address: 
Telephone:
Email:
Affiliation:  Citrus Valley Medical Research, Inc.
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Female Subject must be between the age eighteen (18) years and sixty four (64)

2. Subject must weigh 110lbs (50kg) or greater

3. Willing and able to provide an informed consent

4. Diagnosed with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)

5. Symptoms of IC/PBS that are moderate to severe (intermittent or chronic) for = three
(3) months

6. 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

7. At screening subject must have a score = four (4) out of ten (10) On Visual Analogue
Pain Scale (VAS Pain Scale)

8. Subject must have a score on the O'Leary/Sant scale of at least a five (5) on the
symptom index at screening

9. Voids greater than eight (8) in a twenty four (24) hour period

10. Nocturia of at least one (1) time during sleeping period

11. 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

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) 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

2. 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.

3. Current use of TENS (Transcutaneous Electrical Nerve Stimulation) or Interstim unit

4. 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

5. 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)

6. Use of illegal drugs by self-reporting

7. History of drug or alcohol abuse within five (5) years of screening visit

8. History of suicide attempt or suicidal thoughts by self-reporting within five (5)
years of screening visit

9. 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

10. A diagnosis of a severe neuro-psychiatric disease

11. Subject demonstrates an absence of nocturia

12. Subject's frequency of urination is equal to or less than eight (8) times in a twenty
four (24) hour period.

13. Subject's symptoms relieved by antimicrobials, urinary antiseptics, anticholinergics,
or antispasmodics.

14. Subject has recurrent bladder or lower urethral calculi (recurrent is defined as > to
3 times in a 12 month period)

15. Subject has active genital herpes with a (3) three month period of the screening
visit

16. Subject has uterine, cervical, vaginal, or urethral cancer

17. Subject has been administered cyclophosphamide or any agent that causes chemical
cystitis

18. Subject has tubercular cystitis

19. Subject has radiation cystitis

20. Subject has benign or malignant bladder tumor

21. Subject has a positive pathologic vaginal culture within three (3) months of the
screening visit

22. Subject has evidence of vesicle ureteral reflux or urethral diverticula

23. Subject has neurogenic bladder dysfunction

24. Subject has a prior urinary diversion

25. 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

26. Subject who is pregnant or lactating

27. Subject with history of hydro-distention within four (4) weeks of baseline visit

28. 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

29. 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.

30. Subject over sixty four (64) years of age

31. Subject who weighs less than 110lbs (50kg)

32. Subject with history of any clinically significant blood chemistry,



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
Intervention(s)
Drug: Ketorolac Tromethamine
Primary Outcome(s)
Pain Scores on the Visual Analog Scale [Time Frame: 5 days]
Secondary Outcome(s)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: 5 days]
Secondary ID(s)
0703-2012-SPRIX
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history