Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00746681
First received: April 2, 2008
Last updated: December 18, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: Tolterodine & Pregabalin Drug: Tolterodine Drug: Placebo Drug: Pregabalin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in mean voided volume per micturition (from baseline). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Percentage and absolute change in urgency episode frequency [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Mean severity of urgency episodes [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Percentage and absolute change in micturition frequency [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Percentage and absolute change in normalized micturition frequency (NMF) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Patient perception of their urinary urgency (using the OAB-q symptom severity scale) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
- Patient Perception of Bladder Condition (PPBC) scale [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
| Enrollment: | 188 |
| Study Start Date: | December 2005 |
| Study Completion Date: | November 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
|
Drug: Tolterodine & Pregabalin
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
|
|
Active Comparator: B
Tolterodine SR 4 mg once daily
|
Drug: Tolterodine
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
|
|
Placebo Comparator: C
Placebo
|
Drug: Placebo
Placebo, Oral, twice daily for 4 weeks
|
|
Experimental: D
Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
|
Drug: Tolterodine & Pregabalin
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
|
|
Experimental: E
Pregabalin 150 mg twice daily
|
Drug: Pregabalin
Pregabalin, Oral, 150 mg twice daily for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women > 18 years Old
- Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746681
Locations
| Czech Republic | |
| Pfizer Investigational Site | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Pfizer Investigational Site | |
| Praha 1, Czech Republic, 110 00 | |
| Pfizer Investigational Site | |
| Praha 3, Czech Republic, 130 00 | |
| Pfizer Investigational Site | |
| Praha 4 - Krc, Czech Republic, 140 59 | |
| Pfizer Investigational Site | |
| Usti Nad Labem, Czech Republic, 401 13 | |
| Lithuania | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, LT-47144 | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, LT-50009 | |
| Pfizer Investigational Site | |
| Vilnius, Lithuania, LT-01118 | |
| Pfizer Investigational Site | |
| Vilnius, Lithuania, LT-08661 | |
| Norway | |
| Pfizer Investigational Site | |
| Haugesund, Norway, 5507 | |
| Pfizer Investigational Site | |
| Moelv, Norway, N-2390 | |
| Pfizer Investigational Site | |
| Trondheim, Norway, 7006 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 901 01 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 040 11 | |
| Pfizer Investigational Site | |
| Martin, Slovakia | |
| Pfizer Investigational Site | |
| Skalica, Slovakia, 909 82 | |
| Sweden | |
| Pfizer Investigational Site | |
| Lulea, Sweden, 97180 | |
| Pfizer Investigational Site | |
| Norrkoping, Sweden, 601 82 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 141 86 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Dundee, Tayside, United Kingdom, DD1 9SY | |
| Pfizer Investigational Site | |
| Bristol, United Kingdom, BS10 5NB | |
| Pfizer Investigational Site | |
| Dundee, United Kingdom, DD1 9SY | |
| Pfizer Investigational Site | |
| Plymouth, United Kingdom, PL6 8DH | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00746681 History of Changes |
| Other Study ID Numbers: | A8881001 |
| Study First Received: | April 2, 2008 |
| Last Updated: | December 18, 2009 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Pregabalin Phenylpropanolamine Tolterodine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anticonvulsants Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Nasal Decongestants Vasoconstrictor Agents |
ClinicalTrials.gov processed this record on June 18, 2013