Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder - Full Text View

Purpose

The purpose of this study is to compare the efficacy of DITROPANÂ® XL (oxybutynin chloride) Extended-Release Tablets and DETROLÂ® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPANÂ® XL (oxybutynin chloride) and DETROLÂ® LA (tolterodine tartrate) during a 12-week treatment period.

Condition	Intervention	Phase
Urinary Incontinence	Drug: oxybutynin chloride	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Comparison of the Efficacy and Tolerability of DITROPAN XL and DETROL LA in the Treatment of Overactive Bladder

Resource links provided by NLM:

MedlinePlus related topics: Bedwetting Overactive Bladder Urinary Incontinence

Drug Information available for: Oxybutynin chloride Oxybutynin Tolterodine Tolterodine tartrate

U.S. FDA Resources

Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:

The number of weekly urge urinary incontinence (Urge-UI) episodes at week 12, adjusted for the baseline value

Secondary Outcome Measures:

The number of total urinary incontinence (Total-UI) episodes at week 12; Void frequency at week 12; Urge-UI ,Total-UI, and Void frequence at weeks 2, 4, and 8; tolerability of the treatments during the 12-week treatment phase.


Enrollment:	790
Study Completion Date:	December 2002

Detailed Description:

The objective of this study is to compare the efficacy and tolerability of DITROPAN® XL 10 mg once-daily and DETROL® LA 4 mg once-daily in the reduction of urge urinary incontinence episodes in female patients with overactive bladder. This is a multicenter, randomized, double-blind, parallel-group study with two active treatments. Screened patients are qualified for the study based on information obtained from seven consecutive 24-hour urinary diaries completed during the Baseline Week, and other eligibility criteria. Qualifying patients receive 12 weeks of treatment with DITROPAN® XL or DETROL® LA, with clinical visits at the end of Weeks 2, 4, 8, and 12.

Safety evaluations during the study include the collection of adverse events, laboratory tests including blood chemistry and urinalysis, physical examinations, vital signs (blood pressure and heart rate) and post-void residual urine volume. Over-encapsulated DITROPAN® XL, 10 mg tablets once-daily by mouth or over-encapsulated DETROL® LA, 4 mg capsules once daily by mouth. The treatment phase of the study runs for 12 weeks.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants who are able to differentiate urinary incontinence episodes associated with urgency from urinary incontinence episodes not associated with urgency
during the 7 day baseline period have 21 to 60 urge urinary incontinence (Urge-UI) episodes, a greater number of Urge-UI episodes than urinary incontinence not associated with urge, and an average of 10 or more voids per 24 hours
are in good general health as determined by medical history, physical examination (general, genital, pelvic, and rectal), laboratory tests and urinalysis
if taking antihypertension medication, must be on a stable dose
and if of child-bearing potential, practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 2 and Visit 3

Exclusion Criteria:

Participants with known, treatable genitourinary conditions (identified on history or on examination) that may cause incontinence (e.g., urinary tract infection, interstitial cystitis, urinary tract obstruction, urethral diverticulum, bladder tumor, bladder stone)
have given birth or have had pelvic, vaginal or bladder surgery less than 6 months before study enrollment
with a second post-void residual urine volume > 150 mL at the time of screening (determined by abdominal ultrasound)
with significant medical problems or other organ abnormality that places them at risk from participating in the study or at a significant risk of developing complete urinary retention
with significant impairment of the liver or kidneys as determined by laboratory assessments or hematuria (red blood cells in microscopic urinalysis)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293839

Sponsors and Collaborators

Alza Corporation, DE, USA

Investigators


Study Director:	Alza Corporation Clinical Trial	ALZA

More Information

Publications:

Diokno AC, Appell RA, Sand PK, Dmochowski RR, Gburek BM, Klimberg IW, Kell SH; OPERA Study Group. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial. Mayo Clin Proc. 2003 Jun;78(6):687-95.


ClinicalTrials.gov Identifier:	NCT00293839 History of Changes
Other Study ID Numbers:	CR004570
Study First Received:	February 16, 2006
Last Updated:	December 7, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:


bladder overactive

Additional relevant MeSH terms:


Urinary Incontinence Enuresis Urinary Bladder, Overactive Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders Mental Disorders Urinary Bladder Diseases Oxybutynin Tolterodine Tartrate	Mandelic Acids Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Urological Agents Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents

ClinicalTrials.gov processed this record on September 28, 2016