NCT00408954CompletedPhase 2
A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Study Overview
Brief Summary
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥
- •Clinical diagnosis of BPH
- •Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
- •Urodynamically defined bladder outlet obstruction
Exclusion Criteria
- •prostate cancer
- •Post-void residual urine volume >200 ml
- •Documented UTI
- •History of relevant urological surgery
Arms & Interventions
Placebo
Placebo Comparator
Intervention: UK-369,003 (Drug)
UK-369,003
Active Comparator
Intervention: UK-369,003 (Drug)
Outcomes
Primary Outcomes
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Time Frame: Duration of study
Secondary Outcomes
- Maximum flow rate (Qmax)(Duration of study)
- Cystometric capacity(Duration of study)
- Post void residual volume (PVR)(Duration of study)
- Average flow rate (Qave)(Duration of study)
- Volume at first unstable contraction(Duration of study)
- Average detrusor pressure during micturition(Duration of study)
- Detrusor pressure at maximum flow rate (PdetQmax)(Duration of study)
- Bladder outlet obstruction index (BOOI)(Duration of study)
- Bladder contractility index (BCI)(Duration of study)
- Bladder voiding efficiency (BE)(Duration of study)
- Frequency of unstable contractions(Duration of study)
- International Prostate Symptom Score (IPSS)(Duration of study)
- Mean amplitude of unstable contractions(Duration of study)
- Patient Reported Treatment Impact (PRTI)(Duration of study)
Investigators
Study Sites (1)
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