Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms (SUNRISE)
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| ClinicalTrials.gov Identifier: NCT00801944 |
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Recruitment Status :
Completed
First Posted : December 4, 2008
Last Update Posted : September 18, 2014
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Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
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Brief Summary:
Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Bladder, Overactive | Drug: Solifenacin succinate Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 973 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial |
| Study Start Date : | April 2004 |
| Actual Primary Completion Date : | October 2005 |
| Actual Study Completion Date : | October 2005 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: I
Solifenacin succinate 5/10mg
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Drug: Solifenacin succinate
oral
Other Names:
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Experimental: II
Placebo
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Drug: Placebo
oral |
Primary Outcome Measures :
- Change from baseline in mean number of urgency episodes/24 hours at EOS -from the Patient Perception of Intensity of Urgency Scale at void (PPIUS) grades 3 and 4 [ Time Frame: Week 16 ]
Secondary Outcome Measures :
- Change from baseline in mean number of urgency episodes (PPIUS grades 1-4) [ Time Frame: Week 16 ]
- Change from baseline in the mean number of micturition, incontinence and urge incontinence (PPIUS grade 4) episodes per 24 hours [ Time Frame: Week 16 ]
- Change from baseline in patient perception of bladder condition (PBC) [ Time Frame: Week 16 ]
- Change from baseline in patient perception of urgency 'bother' (UB-VAS) [ Time Frame: Week 16 ]
- Percentage of patients requiring an increase in the dose of the study medication [ Time Frame: Week 8 ]
- Patient assessment of treatment satisfaction (TS-VAS) [ Time Frame: Weeks 4, 8 and 12 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient is willing and able to complete the micturition diary correctly.
- Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for >= 3 months
- At least 3 episodes of urgency with or without incontinence in last 3 days
- At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
- Patient must experience frequency of micturition on average >= 8 times per 24-hour period during the 3-day micturition diary period
Exclusion Criteria:
- Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives
- Clinically significant outflow obstruction (at the discretion of the investigator)
- Significant post void residual volume (PVR>200ml)
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
- Patient with indwelling catheters or practising intermittent self-catheterisation
- Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
- Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
- Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
- Use of drugs intended to treat urinary incontinence
- Diabetic neuropathy
- Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
- Participation in any clinical trial within 30 days prior to randomisation
- Employees of the Yamanouchi Group, third parties associated with the study, or the study site
- Patient who did not complete the micturition diary according to the instructions
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801944
Locations
Show 78 study locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Central Contact | Astellas Pharma Europe B.V. |
Additional Information:
Publications:
Publications:
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00801944 |
| Other Study ID Numbers: |
905-EC-002 |
| First Posted: | December 4, 2008 Key Record Dates |
| Last Update Posted: | September 18, 2014 |
| Last Verified: | September 2014 |
Keywords provided by Astellas Pharma Inc:
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Overactive Bladder |
Additional relevant MeSH terms:
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Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Lower Urinary Tract Symptoms Urological Manifestations |
Solifenacin Succinate Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |