Overactive Bladder (OAB)Phase 4NCT00282932
Detrol LA In Men With Overactive Bladder.
A Phase 4 study testing Detrol LA in people with Overactive Bladder (OAB), run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 81 sites in 15 countries.
Trial summary
An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- Detrol LA
- How many people
- 600 participants
- Where
- 81 sitesin 15 countries
- Study dates
- Jan 2006to 14 May 2007
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary)
Who cannot join
- Significant hepatic or renal disease, history of radiation treatment
Trial locations and contacts
81 sites in 15 countries.
81 sites in 15 countries
Canada12 sites
Pfizer Investigational Site
Calgary, Alberta, T2V 4R6
Pfizer Investigational Site
Kingston, Ontario, K7L 3J7
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Montreal, Quebec, H2X 1N8
Pfizer Investigational Site
Montreal, Quebec, H3S 1Z1
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Surrey, British Columbia, V3V 1N1
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5T 2S8
Pfizer Investigational Site
Toronto, Ontario, M6A 3B5
Pfizer Investigational Site
Victoria, British Columbia, V8T5G1
United States11 sites
Pfizer Investigational Site
Anaheim, California, 92801
Pfizer Investigational Site
Aurora, Colorado, 80012
Pfizer Investigational Site
Cincinnati, Ohio, 45212
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Iowa City, Iowa, 52242-1089
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
State College, Pennsylvania, 16801
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
Woodlane, New Jersey, 08060
Germany8 sites
Pfizer Investigational Site
Berlin, 13347
Pfizer Investigational Site
Duisburg, 47179
Pfizer Investigational Site
Frankfurt, 65929
Pfizer Investigational Site
Muelheim A.d. Ruhr, 45468
Pfizer Investigational Site
München, 81369
Pfizer Investigational Site
München, 81925
Pfizer Investigational Site
Rosenheim, 83022
Pfizer Investigational Site
Starnberg, 82319
Spain7 sites
Pfizer Investigational Site
A Coruña, A Coruña, 15006
Pfizer Investigational Site
Barcelona, 08025
Pfizer Investigational Site
Granada, 18014
Pfizer Investigational Site
Madrid, 28016
Pfizer Investigational Site
Madrid, 28040
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, 07014
Pfizer Investigational Site
Valencia, 46009
South Africa6 sites
Pfizer Investigational Site
Bloemfontein, Free State, 9300
Pfizer Investigational Site
Bloemfontein, Free State, 9301
Pfizer Investigational Site
Cape Town, 8001
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
Parktown, Gauteng, 2193
Pfizer Investigational Site
Pietermaritzburg, KwaZulu-Natal, 3201
Mexico5 sites
Pfizer Investigational Site
Durango, 34000
Pfizer Investigational Site
Durango, 34079
Pfizer Investigational Site
Guadalajara, Jalisco, 44100
Pfizer Investigational Site
Tlalpan, México DF, 14000
Pfizer Investigational Site
Zapopan, Jalisco, 45200
Slovakia5 sites
Pfizer Investigational Site
Bratislava, 833 05
Pfizer Investigational Site
Košice, 040 11
Pfizer Investigational Site
Malacky, 901 01
Pfizer Investigational Site
Martin, 036 01
Pfizer Investigational Site
Skalica, 909 82
South Korea4 sites
Pfizer Investigational Site
Bucheon-si, Gyunggi-do, 420-717
Pfizer Investigational Site
Busan, 602-739
Pfizer Investigational Site
Seoul, 135-270
Pfizer Investigational Site
Seoul, 138-736
Sweden4 sites
Pfizer Investigational Site
Borås, 503 32
Pfizer Investigational Site
Huskvarna, 561 36
Pfizer Investigational Site
Lund, 221 85
Pfizer Investigational Site
Skövde, 541 30
Taiwan4 sites
Pfizer Investigational Site
Hualien City, 970
Pfizer Investigational Site
Kaohsiung City, 833
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei
Turkey (Türkiye)4 sites
Pfizer Investigational Site
Adana, 01230
Pfizer Investigational Site
Istanbul
Pfizer Investigational Site
Izmir, 35100
Pfizer Investigational Site
Sihhiye-Ankara
United Kingdom4 sites
Pfizer Investigational Site
Bristol, Avon, BS10 5NB
Pfizer Investigational Site
Crewe, Cheshire, CW1 4QJ
Pfizer Investigational Site
London, N19 5LW
Pfizer Investigational Site
Taunton, Somerset, TA1 5DA
Denmark3 sites
Pfizer Investigational Site
Aalborg, 9100
Pfizer Investigational Site
Herlev, DK-2730
Pfizer Investigational Site
Nykøbing Falster, 4800
Italy2 sites
Pfizer Investigational Site
Latina, 04100
Pfizer Investigational Site
Padova, 35128
Norway2 sites
Pfizer Investigational Site
Bodø, 8087
Pfizer Investigational Site
Moelv, 2391
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.
An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.
Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).
Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.
- Conditions
- Overactive Bladder (OAB)
- Being tested
- Detrol LA
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detrol LADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Perception of Bladder Condition at 12 weeks of treatment
Secondary outcomes (6)
1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
incontinence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJan 2006
- Primary completion1 May 2007
- Study completion14 May 2007
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 Bladder (OAB)Studies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282932
- Sponsor's protocol ID
- A6121127
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2006
- Last updated
- 27 Jan 2021
- Results posted
- No
Publications
Chapple C, Herschorn S, Abrams P, Sun F, Brodsky M, Guan Z. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.
PubMed 19070418
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.
- ClinicalTrials.gov ID
- NCT00282932
- Acronym / sponsor ID
- A6121127
- Conditions
- Overactive Bladder (OAB)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- 1 May 2007 (actual)
- Study completion
- 14 May 2007 (actual)
- First posted
- 27 Jan 2006 (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.
An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.
Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).
Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary)
Key exclusion criteria (1 listed)
- Significant hepatic or renal disease, history of radiation treatment
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 |
|---|---|---|
| Detrol LA | Drug | – |
Primary outcome
Patient Perception of Bladder Condition at 12 weeks of treatment
6 secondary outcomes
1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
incontinence.
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 27 Jan 2021.
- Derived from this study: PubMed 19070418Chapple C, Herschorn S, Abrams P, Sun F, Brodsky M, Guan Z. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
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Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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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.
Pfizer CT.gov Call Center study director
Pfizer
81 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Detrol LA in people with Overactive Bladder (OAB), run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 81 sites in 15 countries.
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 1 inclusion and 1 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in Canada, United States, Germany, Spain, South Africa and 10 more countries. 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?
Patient Perception of Bladder Condition at 12 weeks of treatment. 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 NCT00282932, 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 27 Jan 2021.