 |
8 Diseases |  |
1 Trial |
|
1 Trial |  |
27 News |  |
- | Validive (clonidine MBT) / Monopar Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - May 31, 2023
P2b, N=190, Terminated, Sponsor: Monopar Therapeutics
N=330 --> 190 | Trial completion date: Dec 2025 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Feb 2024 --> May 2023; Interim Analysis did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo.
- || Validive (clonidine MBT) / Monopar Therap
Trial completion date, Trial primary completion date: VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - Dec 1, 2022
P2b, N=330, Recruiting, Sponsor: Monopar Therapeutics
N=330 --> 190 | Trial completion date: Dec 2025 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Feb 2024 --> May 2023; Interim Analysis did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jul 2023 --> Feb 2024
- Validive (clonidine MBT) / Monopar Therap
[VIRTUAL] Rationale and design of the phase IIb/III VOICE trial of clonidine MBT for the prevention of severe oral mucositis in patients with OPC receiving chemoradiotherapy () - Aug 15, 2021 - Abstract #ESMO2021ESMO_3302;
P2b
2021. Approximately 50 US and EU sites are planned with completion of patient enrollment scheduled to finish in late 2022.
- | Validive (clonidine MBT) / Monopar Therap
Enrollment open: VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - Dec 7, 2020
P2b, N=260, Recruiting, Sponsor: Monopar Therapeutics
Approximately 50 US and EU sites are planned with completion of patient enrollment scheduled to finish in late 2022. Not yet recruiting --> Recruiting
- | Validive (clonidine MBT) / Monopar Therap
New P2b trial: VOICE: Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer. (clinicaltrials.gov) - Nov 30, 2020
P2b, N=260, Not yet recruiting, Sponsor: Monopar Therapeutics
- | Validive (clonidine MBT) / Monopar Therap
Trial completion: Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers (clinicaltrials.gov) - Apr 18, 2016
P1, N=36, Completed, Sponsor: Onxeo
Not yet recruiting --> Recruiting Recruiting --> Completed
- | Validive (clonidine MBT) / Monopar Therap
New P1 trial: Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers (clinicaltrials.gov) - Sep 14, 2015
P1, N=36, Not yet recruiting, Sponsor: Onxeo
- Validive (clonidine MBT) / Monopar Therap
Trial completion: Efficacy and Safety Study of Clonidine Lauriad (clinicaltrials.gov) - Feb 5, 2015
P2, N=183, Completed, Sponsor: Onxeo
Recruiting --> Completed Recruiting --> Completed