Web-based Methodology Trial to Evaluate the Efficacy and Safety of Tolterodine ER in Subjects With Overactive Bladder (REMOTE)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01302938
First received: February 22, 2011
Last updated: August 30, 2012
Last verified: August 2012
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Purpose
To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: Tolterodine ER Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Exploratory, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Center, Web-Based Phase IV Pilot Methodology Trial To Evaluate The Efficacy And Safety Of Tolterodine ER In Subjects With Overactive Bladder |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To compare the efficacy of tolterodine ER to placebo in subjects with overactive bladder after 12 weeks of treatment using an innovative web-based trial design [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in mean voided volume per micturition at weeks 1, 4, and 12 relative to baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at week 1, 4, and 12 relative to the baseline (UUI episodes are defined as those with Bladder Sensation Scale rating of 5 in the diary). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in mean number of micturitions per 24 hours at weeks 1 and 4 relative to baseline. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in mean number of nighttime micturitions per 24 hours and nocturnal urgency at weeks 1, 4, and 12 relative to baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in mean number of urgency episodes per 24 hours at weeks 1, 4, and 12 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of 3 or greater in the diary). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Patient Perception of Bladder Condition (PPBC) at weeks 1, 4, and 12 relative to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Patient Perception of Urgency Scale (PPUS) at weeks 1, 4, and 12 relative to baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Overactive Bladder Questionnaire (OAB-q) symptom bother score and change in score of each HRQL (health related quality of life) domain and the total score of the OAB-q at week 12 relative to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Patient reported satisfaction with trial conduct as assessed by the "Patient Experience Questionnaire". [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Incidence, severity, and relatedness to treatment of all reported and treatment emergent Adverse Events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Withdrawals from the trial due to Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- The number of patients with Serious Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Safety laboratory results [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | March 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tolterodine ER |
Drug: Tolterodine ER
One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.
|
| Placebo Comparator: Placebo |
Drug: Placebo
A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female and 21 years or older
- Overactive bladder symptoms (subject-reported) for at least 3 months
- Be resident in the United States of America and have access and be able to use a computer with internet access throughout the duration of the study
Exclusion Criteria:
- Clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or Parkinson's disease.
- History of cystitis, continence, urogenitalcancer or radiation
- Subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302938
Locations
| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94121 | |
| Mytrus, Inc. | |
| San Francisco, California, United States, 94104 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01302938 History of Changes |
| Other Study ID Numbers: | A6121195 |
| Study First Received: | February 22, 2011 |
| Last Updated: | August 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Double-blind Placebo-controlled frequency urgency web-based incontinence |
methodology ediary safety efficacy tolerability ER overactive bladder |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Tolterodine Phenylpropanolamine Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Appetite Depressants Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013