Overactive BladderPhase 4OABNCT01833663
Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women
A Phase 4 study testing Solifenacin Succinate Tablets and Estrogen in people with Overactive Bladder and Postmenopausal Disorder, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a multi-site, randomized, opened and parallel-controlled clinical study. The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder, Postmenopausal Disorder, Urination Disorders
- What is being tested?
- Solifenacin Succinate Tablets and Estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women aged ≤75.
- Signing of ICF.
- Willing to and able to correctly complete the urination diary.
- Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence).
- No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary.
Who cannot join
- Clinically-significant dysuria(at the investigators' viewpoints).
- Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators.
- At the ongoing intubatton or the intermittent self-intubatton.
- Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors.
- Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints.
- Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study).
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- Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions
- Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose.
- Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints.
- Participation in other clinical studies within 30d before the random grouping.
- No completion of urination diary according to relevant instructions.
- Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women
This study is a multi-site, randomized, opened and parallel-controlled clinical study.
The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.
- Being tested
- Solifenacin Succinate Tablets, Estrogen
- Keywords
- Overactive Bladder, Solifenacin Succinate Tablets, Estrogen
- Medical subject headings
- Urinary Bladder, Overactive, Urination Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin Succinate TabletsDrug
EstrogenDrug
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin Succinate Tablets and Estrogen capsules | Experimental | Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks Receives: Drug: Solifenacin Succinate Tablets; Drug: Estrogen |
| Solifenacin Succinate Tablets | Active comparator | Solifenacin Succinate Tablets (5mg/d) for 12 weeks Receives: Drug: Solifenacin Succinate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the mean urination times (24h) at the end of treatment and the baseline value
Measured: 12 weeks
Secondary outcomes (1)
Difference between the mean urgent micturition times (24h) and the baseline value
Measured: on week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lan Zhu, doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833663
- Sponsor's protocol ID
- XH-WXK-001
- Acronym
- OAB
- Status last verified
- Mar 2014
- First submitted
- 10 Apr 2013
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women
- ClinicalTrials.gov ID
- NCT01833663
- Acronym / sponsor ID
- OAB / XH-WXK-001
- Keywords
- Overactive Bladder, Solifenacin Succinate Tablets, Estrogen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma China, Inc., Beijing CAT Science Co., Ltd.
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-site, randomized, opened and parallel-controlled clinical study.
The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin Succinate Tablets and Estrogen capsules | Experimental | Drug: Solifenacin Succinate Tablets, Drug: EstrogenSolifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks |
| Solifenacin Succinate Tablets | Active comparator | Drug: Solifenacin Succinate TabletsSolifenacin Succinate Tablets (5mg/d) for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Post-menopausal women aged ≤75.
- Signing of ICF.
- Willing to and able to correctly complete the urination diary.
- Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence).
- No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary.
Key exclusion criteria (12 listed)
- Clinically-significant dysuria(at the investigators' viewpoints).
- Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators.
- At the ongoing intubatton or the intermittent self-intubatton.
- Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors.
- Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solifenacin Succinate Tablets | Drug | Solifenacin Succinate Tablets, Solifenacin Succinate Tablets and Estrogen capsules |
| Estrogen | Drug | Solifenacin Succinate Tablets and Estrogen capsules |
Primary outcome
Difference between the mean urination times (24h) at the end of treatment and the baseline value
Time frame: 12 weeks
1 secondary outcome
Difference between the mean urgent micturition times (24h) and the baseline value
Time frame: on week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan Zhu, doctor principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solifenacin Succinate Tablets and Estrogen in people with Overactive Bladder and Postmenopausal Disorder, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the mean urination times (24h) at the end of treatment and the baseline value (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.