A global phase IV, double-blind, placebo-controlled, randomized trial to evaluate the effectiveness of Detrusitol SR 4 mg on Patient's Perception of Bladder Condition (PPBC). - N/A

• Register: EUCTR
• Last refreshed on: 2 August 2021
• Main ID: EUCTR2004-000996-33-DK
• Date of registration: 09/07/2008
• Prospective Registration: No
• Primary sponsor: Pfizer ApS
• Public title: A global phase IV, double-blind, placebo-controlled, randomized trial to evaluate the effectiveness of Detrusitol SR 4 mg on Patient's Perception of Bladder Condition (PPBC). - N/A
• Scientific title: A global phase IV, double-blind, placebo-controlled, randomized trial to evaluate the effectiveness of Detrusitol SR 4 mg on Patient's Perception of Bladder Condition (PPBC). - N/A
• Date of first enrolment: 30/08/2004
• Target sample size: 600
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000996-33
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Denmark, Italy, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects to be included in the study are those:
1. who are outpatients > 18 years of age.
2. with self-reported symptoms of OAB for ³ 3 months prior to Visit 1 (screening).
3. who have OAB as defined by urinary frequency a minimum of 8 micturitions per 24 hours, as confirmed by the diary.
4. who have urgency (defined as a strong and sudden desire to urinate) with at least 3 episodes in 3 days urge incontinence, as confirmed by the micturition bladder diary between Visit 1 (screening) and Visit 2 (baseline).
5. who describe the degree of bothersomeness of their most bothersome OAB symptom as “moderately or more“, “a great deal ”, or “a very great deal” per the OAB Bother Rating Scale.
6. who have had a urinalysis negative for evidence of infection or hematuria within the past 3 months.
7. able and willing to attend all clinic visits.
8. able and willing to complete all micturition diaries and study questionnaires.
9. able to visit the toilet without assistance.
10. capable of understanding the research nature of the treatment and the risk of adverse events, and having signed the informed consent form after full discussion and prior to the initiation of any study related procedures.
11. able, in the opinion of the investigator, to read and follow written instructions and to comply with the requirement of the clinical trial.

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:
Subjects to be excluded are those:
1. who responded “my bladder condition does not cause me any problems at all” on the Patient’s Perception Bladder Condition questionnaire at baseline.
2. with any condition that would contraindicate their usage of Detrusitol SR 4mg once daily (OD), including: narrow angle glaucoma, urinary retention, gastric retention.
3. with an allergic reaction or hypersensitivity to Detrusitol.
4. who have, in the judgment of the investigator, any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria.
5. with stress incontinence, functional, or overflow incontinence as determined by the investigator.
6. with symptomatic acute urinary tract infection (UTI) during the screening period, or recurrent urinary tract infections defined by treatment for symptomatic UTI > 3 times in the 12 months prior to participation in this clinical trial.
7. with clinically significant urinary tract obstruction.
8. with history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months.
9. with clinically significant interstitial cystitis or significant bladder pain syndrome.
10. males with a history of prostate carcinoma treated with external or interstitial radiation, radioactive seeds, or a radical prostatectomy.
11. females with a history of uterine, cervical, vulvar, or vaginal carcinoma treated with external or interstitial radiation.
12. females who have had a radical hysterectomy.
13. females who have pelvic organ prolapse protruding through the introitus at rest in the supine position.
14. with unstable diabetes mellitus in the judgment of the investigator.
15. with spinal cord injury or multiple sclerosis.
16. who have less than 3 bowel movements per week.
17. with indwelling catheter or practicing intermittent self-catheterization.
18. with a history of or documented hepatic or renal dysfunction, defined as serum transaminases, blood urea nitrogen (BUN) or creatinine, greater than twice the upper limit of normal for the laboratory within the past 6 months.
19. who are currently managed with anticholinergics for symptoms of OAB.
20. who have initiated estrogen treatment (topical or systemic) within 4 weeks prior to Visit 1 (screening).
21. treated within 14 days preceding the screening visit, or expected to start therapy during the study treatment period with:
- any drug successfully used to treat urinary urge incontinence.
- concomitant treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics (erythromycin) or antifungal agents (ketoconazole).
22. requirement for intermittent use of diuretics.
23. on an unstable dosage of any drug with anticholinergic side effects within 14 days preceding the screening visit (Visit 1) or expected to start treatment during the trial.
24. who have started any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Visit 1.
25. previously included in this study or patients who have received an investigational drug within 30 days prior to study entry.
26. pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception. Oral contraceptive agent, intrauterine device (IUD), implantable contraceptive, or injectable contraceptive (must have been used for at least 2 months prior to entering the study and continue to use throughout the st

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Overactive bladder syndrome (OAB)

Intervention(s)

Product Name: Detrusitol Retard
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: Tolterodine hydrochloride
Other descriptive name: Detrusitol Retard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Prolonged-release capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: - To culturally and linguistically validate the Pfizer OAB Screener and to determine the ability of the Pfizer OAB Screener to identify patients with urinary symptoms consistent with OAB.
- To determine the relationship of the response to therapy (responsiveness analysis) to micturition diary variables, Overactive Bladder questionnaire (OABq), and PPBC.
- To determine the efficacy of the clinical trial intervention in improving the OAB Symptoms as measured by the absolute and percent changes of OABq, micturition diary variables from baseline to Week 12 and PPBC at Week 1.

Main Objective: To determine the improvement in Patient's Perception of Bladder Condition (PPBC)

Primary end point(s): The primary efficacy measure is the proportion of patients who had any improvement in Patient's Perception of Bladder Condition at week 12.

Secondary ID(s)

A6121122

2004-000996-33-SE

Ethics review

Status: Approved
Approval date: 12/08/2004
Contact:

Results

• Results available: Yes
• Date Posted: 04/08/2016
• Date Completed: 10/03/2005
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2004-000996-33/results