Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00408954
First received: December 6, 2006
Last updated: November 12, 2010
Last verified: November 2010
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Purpose
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Hyperplasia |
Drug: UK-369,003 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Maximum flow rate (Qmax) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Cystometric capacity [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Post void residual volume (PVR) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Average flow rate (Qave) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Volume at first unstable contraction [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Average detrusor pressure during micturition [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Detrusor pressure at maximum flow rate (PdetQmax) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Bladder outlet obstruction index (BOOI) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Bladder contractility index (BCI) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Bladder voiding efficiency (BE) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Frequency of unstable contractions [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- International Prostate Symptom Score (IPSS) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Mean amplitude of unstable contractions [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Patient Reported Treatment Impact (PRTI) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
| Enrollment: | 27 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: UK-369,003
UK-369,003-100 mg MR formulation for 2 weeks
|
| Active Comparator: UK-369,003 |
Drug: UK-369,003
100 mg MR tablet once daily for 2 weeks
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408954
Locations
| Czech Republic | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 612 00 | |
| Pfizer Investigational Site | |
| Hradec Kralove, Czech Republic, 500 02 | |
| Pfizer Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| Pfizer Investigational Site | |
| Usti nad Labem, Czech Republic, 401 13 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Amsterdam, Netherlands, 1081 HV | |
| Pfizer Investigational Site | |
| Nijmegen, Netherlands, 6525 GA | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 833 05 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 040 11 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 041 90 | |
| Pfizer Investigational Site | |
| Martin, Slovakia, 036 59 | |
| Pfizer Investigational Site | |
| Trencin, Slovakia, 911 01 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00408954 History of Changes |
| Other Study ID Numbers: | A3711045 |
| Study First Received: | December 6, 2006 |
| Last Updated: | November 12, 2010 |
| Health Authority: | Slovakia: State Institute for Drug Control |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013