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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. |
Register:
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EUCTR |
Last refreshed on:
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3 December 2012 |
Main ID: |
EUCTR2009-014597-17-SE |
Date of registration:
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28/10/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS)
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Scientific title:
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A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS) |
Date of first enrolment:
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03/05/2010 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014597-17 |
Study type:
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Interventional clinical trial of medicinal product |
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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Countries of recruitment
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Belgium
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Finland
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Germany
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Spain
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: Screen Visit 1 1. Patients must consent in writing to participate in the study by signing and dating an Informed Consent Document indicating that they have been informed of all pertinent aspects of the study prior to completing any of the Screening procedures. 2. Has an appropriate score on the Painful Bladder/Interstitial Cystitis Symptom Score (PBIC-SS), as outlined in the scoring guidance. 3. Male and female outpatients aged =18 years. 4. Female patients must meet one of the following criteria: a. Female patients of non-childbearing potential: post-menopausal, defined as women who are =45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels); amenorrhea for at least 1 year AND have a serum Follicle-Stimulating Hormone (FSH) level greater than 30 IU/L at Screening; or surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy; b. Female patients of child-bearing potential: must not be pregnant or lactating and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method). Women of childbearing potential must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing. Male patients must agree that they and their female spouses/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential. Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of Screening procedures until 16 weeks after the last dose of study medication. In the event of indeterminate or anomalous results on pregnancy/FSH testing or issues surrounding contraceptive requirements, study management should be contacted and will make the final decision as to the adequacy/need for contraception. 5. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, the self-completion of study questionnaires, electronic diary (eDiary), and other trial procedures. 6. Evidence of cystoscopy within 2 years of Screening to confirm the absence of significant lower urinary tract pathology, and the presence or absence of cystoscopic features of IC/PBS (eg, glomerulations, Hunner’s lesion). Note: Cystoscopy is mandated within 2 years of Screening. Patients who have not had cystoscopy within 2 years of Screening must undergo the procedure at Screening. Visit 2, Randomization. The following continuation criteria have to be met in order for patients to be randomized: 7. Completes at least 4 average pain scores within any of the 7 days prior to randomization, with a mean average pain intensity score of =4 (0-10 NRS); the mean average pain intensity score at Baseline is defined as the mean of all 24-hour average pain intensity scores recorded in the 7 days before Visit 2 (Randomization). 8. Mean micturition frequency = 8 per 24 hours over any 3 consecutive days in the previous 7 days prior to Visit 2 (Randomization). 9. Women of childbearing potential must have a negative urine pregnancy test at Visit 2 (Randomization) prior to initial dosing. 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: Patients presenting with any of the following will not be included in the study: 1. Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study. 2. Patients with symptoms of IC/PBS for less than 6 months prior to Screening. 3. Patients with a post-void residual (PVR) volume >200 mL at Screening (Visit 1). 4. Patients with a mean voided volume <40 and >400 mL per micturition as measured over 1 day of the 7-day eDiary period completed prior to Visit 2 (Randomization). 5. Patients with a total daily volume voided of >3500 mL, as confirmed by the eDiary completed prior to Visit 2 (Randomization). 6. Patients with greater than 1+ hematuria on dipstick test at Screening, unless fully investigated prior to randomization to rule out significant urological disease. • Patients who are menstruating may be re-screened once menstruation has ceased if they have been found to have hematuria on dipstick testing. 7. Patients with a microbiologically-proven urinary tract infection at Screening (Visit 1) or Randomization (Visit 2). Patients can be treated and re-screened. 8. Patients with the following medical history and comorbid conditions at Screening [see protocol for table]. 9. Patients who have undergone the following procedures [see protocol for table]. 10. Patients with any of the following conditions at Screening: • Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC). • Passive urinary incontinence (e.g. vesicovaginal fistula). • Not capable of independent voiding. 11. Patients 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. • Patients 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. 12. Taking other treatments for interstitial cystitis at Screening as listed below [see protocol for table]. Patients are prohibited from taking those medications until Week 24, or Early Termination. Note: Patients may remain on ongoing oral medications as background therapy for the treatment of their interstitial cystitis symptoms, provided that they have been administered at a stable dose for at least 3 months prior to Screening and for the duration of the study. 13. Patients who have participated in a previous tanezumab clinical study. 14. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein. 15. Previous exposure to exogenous NGF or to an anti NGF antibody. 16. History of intolerance or hypersensitivity to acetaminophen (paracetamol) or any of its excipients, or existence of a medical condition or concomitant medication for which the use of acetaminophen is contraindicated (refer to product labeling). 17. Patients with a relevant neurological disease at Screening with which their urinary symptoms may be associated (eg, multiple sclerosis, Parkinson’s disease, spinal cord injury, spinal cord lesion, familial neuropathy, spina bifida or diabetic cystopathy); history, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to: • Alzheimer’s disease or other types of dementia. • Clinically significant head trauma within the past year • Peripheral neuropathy
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic pain including the pain of interstitial cystitis/painful bladder syndrome. MedDRA version: 12.0
Level: LLT
Classification code 10008927
Term: Chronic interstitial cystitis
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Intervention(s)
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Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RN624, RI624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RN624, RI624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Product Name: Tanezumab Product Code: PF-04383119 Pharmaceutical Form: Solution for injection INN or Proposed INN: Tanezumab CAS Number: 880266-57-9 Current Sponsor code: PF-04383119 Other descriptive name: RN624, RI624 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To explore the response of IC/PBS urinary endpoints (eg, micturition frequency etc) to tanezumab compared to placebo.
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Main Objective: To characterize the dose response for tanezumab when administered by SC injection at an 8-weekly interval (2 injections) for moderate to severe chronic pain associated with (IC/PBS).
To evaluate the safety and tolerability of tanezumab in the treatment of moderate to severe chronic pain associated with IC/PBS.
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Primary end point(s): The primary endpoint is change from Baseline in mean average daily pain over 7 days at Week 16 as measured by an 11-point Numeric Rating Scale (NRS).
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Source(s) of Monetary Support
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Results
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Results available:
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