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Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

D

Duramed Research

Status and phase

Completed
Phase 2

Conditions

Urinary Incontinence

Treatments

Drug: DR-3001b
Other: Placebo
Drug: DR-3001a

Study type

Interventional

Funder types

Industry

Identifiers

NCT00196404
BR-OXY-202

Details and patient eligibility

About

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Full description

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Enrollment

800 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of overactive bladder and incontinence for at least 6 months
  • Using birth control or menopausal
  • Willing to discontinue current medication for overactive bladder

Exclusion criteria

  • Pregnant or given birth in the last 6 months
  • Three or more urinary tract infections a year
  • Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
  • History of bladder cancer, ulcerative colitis or severe constipation
  • Any contraindication to vaginal delivery systems

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

800 participants in 3 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: DR-3001a
2
Experimental group
Treatment:
Drug: DR-3001b
3
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

48

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Data sourced from clinicaltrials.gov

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