Clonidine HCl MBT vs. Placebo to Prevent Chemoradiotherapy-Induced Severe Oral Mucositis in Oropharyngeal Cancer.
← catalyst calendarSponsored by Monopar Therapeutics (industry) · MNPR — their whole pipeline →.
Phase
Phase 2/3
Status
Terminated
Study type
Interventional
Design
Randomized · Quadruple · Supportive care
Enrollment
190actual
Sites
74
Countries
France, Germany, Puerto Rico +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-09-04
Why the sponsor stopped it
Interim Analysis did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-02-11 | actual | When the study began enrolling |
| Primary completion | 2023-05-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2023-05-14 | actual | The whole study's end, after follow-up |
| First posted | 2020-12-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-05-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chemoradiotherapy-Induced Severe Oral Mucositis
Interventions
- Drug: Clonidine HCl Mucoadhesive Buccal Tablet — also filed as Validive®
- Drug: Placebo Mucoadhesive Buccal Tablet
Primary outcome
what the primary-completion date above is the date OFTo demonstrate the efficacy of HCl MBT to prevent SOM in OPC patients receiving CRT.
measured From the first CRT treatment through the end of the study treatment period, which is estimated to be 7 weeks.
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