Overactive BladderPhase 2NCT00746681
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
A Phase 2 study testing Tolterodine & Pregabalin, Tolterodine and Pregabalin in people with Overactive Bladder, run by Pfizer at 23 sites in 6 countries.
Trial summary
Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tolterodine & Pregabalin, Tolterodine and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 23 sitesin 6 countries
- Study dates
- Dec 2005to Nov 2006
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women > 18 years Old
- Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)
Who cannot join
- Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
- Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
- Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Czechia5 sites
Pfizer Investigational Site
Hradec Králové, 500 05
Pfizer Investigational Site
Prague, 110 00
Pfizer Investigational Site
Prague, 130 00
Pfizer Investigational Site
Praha 4 - Krc, 140 59
Pfizer Investigational Site
Ústí nad Labem, 401 13
Lithuania4 sites
Pfizer Investigational Site
Kaunas, LT-47144
Pfizer Investigational Site
Kaunas, LT-50009
Pfizer Investigational Site
Vilnius, LT-01118
Pfizer Investigational Site
Vilnius, LT-08661
Slovakia4 sites
Pfizer Investigational Site
Bratislava, 901 01
Pfizer Investigational Site
Košice, 040 11
Pfizer Investigational Site
Martin, Slovakia
Pfizer Investigational Site
Skalica, 909 82
United Kingdom4 sites
Pfizer Investigational Site
Bristol, BS10 5NB
Pfizer Investigational Site
Dundee, Tayside, DD1 9SY
Pfizer Investigational Site
Dundee, DD1 9SY
Pfizer Investigational Site
Plymouth, PL6 8DH
Norway3 sites
Pfizer Investigational Site
Haugesund, 5507
Pfizer Investigational Site
Moelv, N-2390
Pfizer Investigational Site
Trondheim, 7006
Sweden3 sites
Pfizer Investigational Site
Luleå, 97180
Pfizer Investigational Site
Norrköping, 601 82
Pfizer Investigational Site
Stockholm, 141 86
About this study
Official title: A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder
Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.
- Conditions
- Overactive Bladder
- Being tested
- Tolterodine & Pregabalin, Tolterodine, Placebo, Pregabalin
- 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.
Tolterodine & PregabalinDrug
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
TolterodineDrug
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
PlaceboDrug
Placebo, Oral, twice daily for 4 weeks
Tolterodine & PregabalinDrug
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
PregabalinDrug
Pregabalin, Oral, 150 mg twice daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily Receives: Drug: Tolterodine & Pregabalin |
| B | Active comparator | Tolterodine SR 4 mg once daily Receives: Drug: Tolterodine |
| C | Placebo comparator | Placebo Receives: Drug: Placebo |
| D | Experimental | Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily Receives: Drug: Tolterodine & Pregabalin |
| E | Experimental | Pregabalin 150 mg twice daily Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean voided volume per micturition (from baseline).
Measured: 4 weeks
Secondary outcomes (8)
Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
Measured: 4 Weeks
Percentage and absolute change in urgency episode frequency
Measured: 4 Weeks
Mean severity of urgency episodes
Measured: 4 Weeks
Percentage and absolute change in micturition frequency
Measured: 4 Weeks
Percentage and absolute change in normalized micturition frequency (NMF)
Measured: 4 Weeks
Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
Measured: 4 Weeks
Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
Measured: 4 Weeks
Patient Perception of Bladder Condition (PPBC) scale
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startDec 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746681
- Sponsor's protocol ID
- A8881001
- Status last verified
- Dec 2009
- First submitted
- 2 Apr 2008
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT00746681
- Acronym / sponsor ID
- A8881001
- Conditions
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 4 Sep 2008 (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.
Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tolterodine & PregabalinTolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily |
| B | Active comparator | Drug: TolterodineTolterodine SR 4 mg once daily |
| C | Placebo comparator | Drug: PlaceboPlacebo |
| D | Experimental | Drug: Tolterodine & PregabalinTolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily |
| E | Experimental | Drug: PregabalinPregabalin 150 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women > 18 years Old
- Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)
Key exclusion criteria (3 listed)
- Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
- Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
- Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
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 |
|---|---|---|
| Tolterodine & PregabalinTolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks | Drug | A |
| TolterodineTolterodine SR, Oral, 4 mg, once daily for 4 weeks | Drug | B |
| PlaceboPlacebo, Oral, twice daily for 4 weeks | Drug | C |
| Tolterodine & PregabalinTolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks | Drug | D |
| PregabalinPregabalin, Oral, 150 mg twice daily for 4 weeks | Drug | E |
Primary outcome
Change in mean voided volume per micturition (from baseline).
Time frame: 4 weeks
8 secondary outcomes
Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
Time frame: 4 Weeks
Percentage and absolute change in urgency episode frequency
Time frame: 4 Weeks
Mean severity of urgency episodes
Time frame: 4 Weeks
Percentage and absolute change in micturition frequency
Time frame: 4 Weeks
Percentage and absolute change in normalized micturition frequency (NMF)
Time frame: 4 Weeks
Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
Time frame: 4 Weeks
Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
Time frame: 4 Weeks
Patient Perception of Bladder Condition (PPBC) scale
Time frame: 4 Weeks
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 21 Dec 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolterodine & Pregabalin, Tolterodine and Pregabalin in people with Overactive Bladder, run by Pfizer at 23 sites in 6 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 2 inclusion and 3 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 21 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Czechia, Lithuania, Slovakia, United Kingdom, Norway and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in mean voided volume per micturition (from baseline). (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2009.