| December 18, 2007 |
| October 20, 2009 |
| February 2008 |
| July 2009 (final data collection date for primary outcome measure) |
| Number of episodes of urgency and frequency of micturition. [ Time Frame: Week 12 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00578097 on ClinicalTrials.gov Archive Site |
- The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Maximum flow rate and post-micturition residual volume (PMRV). [ Time Frame: Day 4 and Week 6 ] [ Designated as safety issue: No ]
- Standard International Continence Society (ICS) urodynamic parameters. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Quality of Life (QoL). [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Safety [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]
- Extension study - Duration of effect as determined by the persistence of a positive response. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study - Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study Quality of Life (QoL) [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study safety. [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]
|
- The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Maximum flow rate and post-micturition residual volume (PMRV). [ Time Frame: Day 4 and Week 6 ] [ Designated as safety issue: No ]
- Standard International Continence Society (ICS) urodynamic parameters. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
- Quality of Life (QoL). [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Safety [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]
- Extension study - Duration of effect as determined by the persistence of a positive response. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study - The number of episodes of urgency, frequency of micturition, and frequency of nocturia. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study - Severity of urgency. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study QoL. [ Time Frame: All timepoints ] [ Designated as safety issue: No ]
- Extension study safety. [ Time Frame: All timepoints ] [ Designated as safety issue: Yes ]
|
| |
| Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder |
| A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder. |
The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Overactive Bladder |
- Drug: Botulinum type A (Dysport®)
- Other: Placebo
|
| |
| |
| |
| Suspended |
| 80 |
| December 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- The subject has a diagnosis of idiopathic overactive bladder, without incontinence.
- The subject has ≥ 3 urgency episodes over the course of the 3 days immediately preceding the Baseline visit.
- The subject has ≥ 24 episodes of micturition over the course of the 3 days immediately preceding the Baseline visit.
Exclusion Criteria:
- Bladder outlet obstruction (on urodynamic assessment).
- Post-Micturition Residual Volume > 150 ml (ultrasound assessment).
- Evidence of a urinary tract infection at Screening or Baseline in the study.
- Active or history of interstitial cystitis, malignancy of the bladder or urothelial tract, a carcinoma in situ (non malignant melanoma is allowed) bladder and/or kidney stones.
|
| Female |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Czech Republic, France, Germany, Italy, Netherlands, Spain, United Kingdom |
| |
| NCT00578097 |
| Benjamin Zakine, Ipsen |
| Y-79-52120-126 |
| Ipsen |
|
| Study Director: |
Benjamin Zakine, MD |
Ipsen |
|
|
| Ipsen |
| October 2009 |
