Phase 2
N=76
Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
Detrusor Underactivity · Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT03175029 ↗Enrolled (actual)
76
Serious AEs
4.0%
Results posted
Jan 2025
Primary outcome: Primary: Changes in the Mean BCI for Male From Baseline to Week 12 — 64.604; 61.339; 75.156; 60.513 Score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAC-302 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Mean BCI for Male From Baseline to Week 12 |
64.604; 61.339; 75.156; 60.513 | <0.001 sig |
| PRIMARY Changes in the Mean PIP1 for Female From Baseline to Week 12 |
18.769; 20.561; 29.373; 25.487 | <0.001 sig |
| SECONDARY Changes in the Mean BVE From Baseline to Week 12 (Overall) |
55.43; 63.71; 66.79; 65.69 | 0.006 sig |
| SECONDARY Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) |
42.77; 55.95; 61.66; 58.83 | <0.001 sig |
| SECONDARY Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) |
32.10; 44.03; 54.71; 46.13 | <0.001 sig |
| SECONDARY Number of Micturitions Per 24 Hours at Baseline and Week 12 |
11.753; 11.764; 10.830; 10.174 | — |
| SECONDARY Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 |
5.452; 5.701; 4.469; 2.493 | — |
| SECONDARY Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 |
8.7; 8.9; 6.5; 7.3 | — |
| SECONDARY Number of Participants With Adverse Events |
24; 9; 0; 1; 1; 2 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions |
0; 0 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
2; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Death |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Dose Discontinuation |
0; 0 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Dose Interruption |
2; 1; 1; 0; 1; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
Eligibility Criteria
Key Inclusion Criteria
- To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry
- To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day.
- To meet the detrusor underactivity criteria by urodynamic study
Key Exclusion Criteria
- Neurogenic bladder by the central nervous system diseases.
- StageIII or more cystocele of pelvic organ prolapse quantification system (women)
- Prostate volume ≥30mL (Men)
- Any symptoms of Urinary tract infection (UTI)
Data sourced from ClinicalTrials.gov (NCT03175029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.