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Main
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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. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2008-002421-37-FR |
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Date of registration:
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26/08/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.
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Scientific title:
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A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME. |
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Date of first enrolment:
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07/10/2008 |
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Target sample size:
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129 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002421-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Denmark
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Finland
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France
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Subjects must meet all of the following criteria to be eligible for enrollment into the study:
Visit 1. The following inclusion criteria have to be met in order for a subject to be
randomized into this trial:
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Male and female subjects aged =18 years.
3. Diagnosis of IC/PBS
4. Evidence of cystoscopy within 2 years of screening to confirm the absence of other significant lower urinary tract pathology and the presence or absence of cystoscopic features of IC (eg glomerulations, Hunner’s ulcer).
Note: Cystoscopy is mandated within 2 years of enrollment. Subjects who have not had cystoscopy within 2 years of screening may undergo the procedure at screening. However placebo run-in would need to be deferred according to the type of cystoscopy performed (exclusion criterion #8).
5. Moderate to severe IC/PBS at screening (Visit 1) as defined by PUF and ICSI total scores:
• PUF total score =13 and
• ICSI total score =7
6. Female subjects must be non-pregnant and non-lactating, and be either, postmenopausal, surgically sterilized, or using an appropriate method of contraception. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (Visit 1). See Section 4.4.1 for further details.
7. Subjects who are willing and able to comply with scheduled visits, the self completion of study questionnaires and symptom diaries, and other trial-related activities.
Visit 2. The following continuation criteria have to be met in order for subjects to be randomized:
8. Completes at least 4 daily pain scores during the 7 days prior to randomization with a mean daily worst pain severity score of =4 (0-10 NRS); the mean severity score is defined as the average of all 24 hr worst pain severity scores recorded in the 7 days prior to randomization.
9. Mean micturition frequency per 24 hours =8 as derived from the symptom diary completed prior to Visit 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Subjects with symptoms of IC/PBS for less than 6 months prior to Screening.
2. Subjects with a post-void residual (PVR) volume >200 mL at Screening (Visit 1).
3. Subjects with a mean voided volume (MVV) <50 mL or > 350 mL measured over 3 consecutive days as verified by the symptom diary prior to randomization (Visit 2).
4. Subjects with a total volume voided of >3000 mL on average per 24 hours, as verified by the symptom diary completed prior to randomization (Visit 2).
5. Subjects with greater than 1+ hematuria on dipstick test at Screening (Visit 1), unless fully investigated prior to randomization to rule out significant urological disease.
• Subjects who are menstruating may be re-screened once menstruation has ceased if they have been found to have hematuria on dipstick testing.
6. Subjects with a microbiologically-proven urinary tract infection at Screening (Visit 1) or randomization (Visit 2).
7. Subjects with the following medical history and co-morbid conditions at Screening (Visit 1):
Any history of: Genitourinary tuberculosis, bladder cancer, urethral cancer, prostate cancer; recurrent urinary tract infection (UTI) – defined as 2 or more UTIs over the past 6 months or 3 or more over the last 1 year; lower urinary tract anatomical anomaly eg, clinically significant (grades 3 to 4) urogenital prolapse, urethral and/or bladder obstruction; pelvic radiotherapy.
History within prior 3 months of:
Bacterial prostatitis; urethritis; active genital herpes.
Less than 6 weeks Bacterial cystitis
Current history of: Proven genitourinary infection including, but not limited to, vaginitis, or yeast infection; symptomatic urinary tract stone.
8. Subjects who have undergone the following procedures:
Any history of: Augmentation cystoplasty, cystectomy or cystolysis, neurectomy Less than 6 months prior to screening:
Urogenital surgery such as hysterectomy, urethral sling procedure, urinary incontinence surgery, trans-vaginal surgery, prolapse surgery, vaginal delivery or cesarean section, prostate surgery or treatment, other bladder or urethral surgery which could interfere with bladder function. Less than 3 months prior to screening:
Formal therapeutic urethral dilatation or urethrotomy Less than 6 weeks prior to screening:
Rigid Cystoscopy, Hydrodistention, laser or electrofulguration of Hunner’s ulcer, prostate biopsy.
Less than 2 weeks Flexible Cystoscopy, bladder biopsy, urodynamic (cystometrogram)
9. Subjects with any of the following conditions at Screening (Visit 1):
• Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC);
• Passive urinary incontinence (eg, vesicovaginal fistula);
• Not capable of independent toileting.
10. Subjects at Screening (Visit 1) who intend to start bladder training program, electrostimulation/neuromodulation therapy (eg, Transcutaneous Electrical Nerve Stimulation (TENS)), acupuncture, or physiotherapy regimen during the study.
• Subjects who are on an established regimen for at least 3 months prior to Screening may remain on this as long as it remains unchanged for the duration of the study.
11. Subjects taking the following treatments for their interstitial cystitis at Screening as noted below:
Prior 6 months:
Any intravesical or transvesical treatment not otherwise specified eg, Botulinum toxin A.
Prior 1 month: Intravesical dimethylsulfoxide (DMSO), Intravesical pentosan polysulphate, sodium hyaluronate, heparin, lidocaine or bupivicaine.
NOTE: Subjects may remain on ong
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME (IC/PBS).
MedDRA version: 9.1
Level: LLT
Classification code 10008927
Term: Chronic interstitial cystitis
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Intervention(s)
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Product Name: PD-0299685
Pharmaceutical Form: Capsule*
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Product Name: PD-0299685
Pharmaceutical Form: Capsule*
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Change from baseline to Week 12 in the worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
Change from baseline to Week 12 in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
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Secondary Objective: To assess the safety and tolerability of PD 0299685.
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Main Objective: To assess the efficacy of PD 0299685 in the treatment of symptoms associated with
interstitial cystitis/painful bladder syndrome including bladder pain, urinary urgency and frequency.
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Secondary ID(s)
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2008-002421-37-DE
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A4291043
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 22/07/2008
Contact:
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