Trials / Completed
CompletedNCT00694915
Study of Mycobacterium w in Superficial Transitional Cell Carcinoma of Bladder
Open Label, Randomized, Multicentric, Comparative and Controlled Clinical Trial to Compare the Efficacy and Toxicity of Mycobacterium w Intra-dermal to Intravesical BCG in Patients With Newly Diagnosed Superficial Transitional Cell Carcinoma With High Probability of Recurrence
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Cadila Pharnmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine and compare the effect of this treatment on recurrence rate and to assess the toxicity in both arms of patients with STCC. Other objectives include determining the effects of this treatment on quality of life, and comparing the effect of Mycobacterium w on time to tumor progression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Mycobacterium w | Immunomodulator |
| BIOLOGICAL | BCG (Bacillus Calmette-Guerin) | Immunotherapeutic agent |
Timeline
- Start date
- 2008-08-28
- Primary completion
- 2014-03-31
- Completion
- 2015-10-07
- First posted
- 2008-06-11
- Last updated
- 2021-08-17
Locations
15 sites across 1 country: India
Source: ClinicalTrials.gov record NCT00694915. Inclusion in this directory is not an endorsement.