Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
This study is enrolling participants by invitation only.
Sponsor:
Asan Medical Center
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Bucheon St.Mary's Hospital
Ajou University
Severance Hospital
Cheil General Hospital and Women’s Healthcare Center
SMG-SNU Boramae Medical Center
Pusan National University Yangsan Hospital
Information provided by (Responsible Party):
Myung-Soo Choo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01437670
First received: September 20, 2011
Last updated: February 11, 2013
Last verified: February 2013
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Purpose
A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin
| Condition | Intervention |
|---|---|
|
Overactive Bladder |
Drug: solifenacin 5mg, 10mg |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin |
Resource links provided by NLM:
MedlinePlus related topics:
Dry Mouth
Drug Information available for:
Solifenacin succinate
U.S. FDA Resources
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- The changes of the total score in Xerostomia inventory XI from baseline [ Time Frame: after 8 weeks of treatment from baseline ] [ Designated as safety issue: No ]11-item summated rating scale. Respondents were asked to choose one of five responses ('never', scoring 1~'very often', 5) total best and worst values: 11 and 49
Secondary Outcome Measures:
- Global response assessment [ Time Frame: after 8 weeks of treatment from baseline ] [ Designated as safety issue: No ]range, 1~7
- The changes of the total score in overactive bladder symptom score (OABSS) from baseline [ Time Frame: after 8 weeks treatment from baseline ] [ Designated as safety issue: No ]total best and worst values: 0 and 15
- Visual Analog Scale (VAS) of dry mouth [ Time Frame: after 8 weeks treatment from baseline ] [ Designated as safety issue: No ]The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0~10)
| Estimated Enrollment: | 262 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
dry mouth patients with solifenacin
dry mouth patients with solifenacin 5mg, 10mg
|
Drug: solifenacin 5mg, 10mg
solifenacin 5mg, 10mg
Other Name: Vesicare
|
Detailed Description:
To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with overactive bladder
- male or female patients with 20 years of age or older
- clinical history of OAB for at least 3 months prior to visit 2
- more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
Criteria
Inclusion Criteria:
- 1) male or female patients with 20 years of age or older 2) clinical history of OAB for at least 3 months prior to visit 2 3) more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
Exclusion Criteria:
- 1) In clinical trial, female with pregnant, intent to become pregnant or breast-feeding 2)post-voided residual urine volume > 150ml 3) a history of catheterization due to acute urinary retention 4) a history of pelvic surgery within 6 months 5) 6) 7) a history of neurovascular disease such as Parkinson's disease, cerebral vascular disease, spinal injury or multiple sclerosis 8)patients with indwelling catheter or intermittent catheterization 9) active or recurrent (>3 episodes per year) urinary tract infection 10) the use of the following medication at least 2 weeks
- anticholinergics
- Tricyclic antidepressants,anti-epilepsy drug, anti-Parkinson's disease drug, anti-arrythmia drug type I
- Chlorpromazine, Thioridazine, Piperazine
- MAO inhibitor 11) Patient is currently taking or has taken within the past 4 weeks alpha-blocker for the treatment of benign prostatic hypertrophy 12) Patient is currently taking or has taken within the past 8 weeks 5ARI or estrogen medication 13) Patient is currently using or has used medications with known activities as inhibitors or inducers of cytochrome P4503A4 (CYP3A4)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437670
Locations
| Korea, Republic of | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-222 | |
Sponsors and Collaborators
Asan Medical Center
Samsung Medical Center
Seoul National University Hospital
Bucheon St.Mary's Hospital
Ajou University
Severance Hospital
Cheil General Hospital and Women’s Healthcare Center
SMG-SNU Boramae Medical Center
Pusan National University Yangsan Hospital
Investigators
| Principal Investigator: | Myoung-Soo Choo, M.D., pH.D. | Asan Medical Center |
More Information
No publications provided
| Responsible Party: | Myung-Soo Choo, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01437670 History of Changes |
| Other Study ID Numbers: | AMC 2011-0585 |
| Study First Received: | September 20, 2011 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013