Diseases / Stomatitis
Stomatitis
DiseaseStomatitis is inflammation of the oral mucosa involving tissues of the mouth or lips. It may arise from infection, irritants, trauma, medications, systemic disease, or cancer therapy and can cause painful oral lesions.
- Trials
- 288
- Recruiting
- 29
- Completed
- 148
- With results
- 35
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | — | 3 | — | 1 | — | 4 |
| Phase 1 | — | — | — | 1 | 12 | 1 | — | — | 14 |
| Phase 1/2 | — | 1 | — | — | 2 | — | 1 | 3 | 7 |
| Phase 2 | 7 | 2 | 1 | 3 | 38 | 6 | 3 | 15 | 75 |
| Phase 2/3 | 1 | — | — | — | 6 | 1 | — | 3 | 11 |
| Phase 3 | 3 | 1 | — | 1 | 21 | 3 | 1 | 6 | 36 |
| Phase 4 | 2 | — | — | — | 6 | 1 | 1 | 4 | 14 |
| Not applicable | 14 | 14 | 1 | 1 | 52 | 5 | — | 18 | 105 |
| Unknown | 2 | 1 | — | 1 | 8 | 2 | 1 | 7 | 22 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Stomatitis | 4 | 14 | 7 | 75 | 11 | 36 | 14 | 105 | 22 | 288 |
| Head and Neck Neoplasms | 1 | 3 | 4 | 18 | 1 | 10 | 2 | 29 | 5 | 73 |
| Mucositis | — | 2 | 1 | 16 | 3 | 5 | 3 | 8 | 5 | 43 |
| Neoplasms | 1 | 1 | 1 | 6 | 3 | 5 | — | 11 | 1 | 29 |
| Ulcer | — | — | 1 | 9 | — | 3 | — | 8 | 4 | 25 |
| Squamous Cell Carcinoma of Head and Neck | — | 2 | 2 | 5 | 1 | 2 | — | 1 | — | 13 |
| Pain | — | 2 | 1 | — | 1 | — | — | 6 | 2 | 12 |
| Oral Ulcer | 1 | — | 1 | 3 | 1 | 2 | — | 3 | — | 11 |
| Nasopharyngeal Carcinoma | — | — | 1 | 6 | — | — | — | 2 | 1 | 10 |
| Mouth Neoplasms | — | 1 | — | 3 | — | — | — | 5 | — | 9 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Cairo University | 8 | 3 |
| 2 | Swedish Orphan Biovitrum | 7 | 2 |
| 3 | Ain Shams University | 6 | 1 |
| 4 | Instituto Nacional de Cancer, Brazil | 6 | 2 |
| 5 | University of Pavia | 5 | 0 |
| 6 | Galera Therapeutics, Inc. | 4 | 1 |
| 7 | M.D. Anderson Cancer Center | 4 | 0 |
| 8 | Sun Yat-sen University | 4 | 1 |
| 9 | Amgen | 3 | 3 |
| 10 | Chang Gung Memorial Hospital | 3 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Low-Level Light Therapy | 22 |
| 2 | Fibroblast Growth Factor 7 | 12 |
| 3 | Cisplatin | 7 |
| 4 | Sodium Bicarbonate | 7 |
| 5 | Cryotherapy | 6 |
| 6 | Laser Therapy | 6 |
| 7 | Propolis | 6 |
| 8 | Saline Solution | 6 |
| 9 | Standard of Care | 6 |
| 10 | Benzydamine | 5 |
Evidence
- Results reported
- 23.6%35 of 148 completed
- Published
- 15.5%23 of 148 completed
- Primary endpoint met
- 18.8%3 of 16 analyses
- Median months to report
- 23
Documents disclosed
Trial profile
- Median enrollment
- 60
- Median duration
- 23.1months
- Countries
- 41
- Study sites
- 1248
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 57
- Phase 1
- 26
- Phase 1/2
- 84
- Phase 2
- 77
- Phase 2/3
- 70
- Phase 3
- 101
- Phase 4
- 72
- Not applicable
- 53
- Unknown
- 60
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Cairo | Egypt | 17 |
| 2 | New York | United States | 13 |
| 3 | Philadelphia | United States | 13 |
| 4 | Milwaukee | United States | 12 |
| 5 | Chicago | United States | 11 |
| 6 | Columbus | United States | 11 |
| 7 | Detroit | United States | 11 |
| 8 | Guangzhou | China | 10 |
| 9 | Shreveport | United States | 10 |
| 10 | Charleston | United States | 9 |
Terminations
- Terminated
- 19
- Withdrawn
- 8
- Stopped for recruitment
- 2.4%7 of 288 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT06708702 Withdrawn | Withdrawn | The study was terminated due to difficulties in including patients because of the slow rate at which patients met the established treatment profile at the proposing institution. | 2026-01-07 |
| NCT05104268 Withdrawn | Withdrawn | Unable to recruit due to the relatively infrequent occurrence of oral mucositis. No participants enrolled | 2025-12-31 |
| NCT05331131 Withdrawn | Withdrawn | Study team not moving forward with protocol | 2025-11-14 |
| NCT03461354 Terminated | Terminated | Interim analysis indicated study closure | 2024-04-01 |
| NCT04648020 Terminated | Terminated | Interim Analysis did not meet the pre-defined threshold for efficacy of a 15% absolute difference in SOM prevention between Validive and placebo. | 2023-05-14 |
| NCT04110977 Terminated | Terminated | After the planned interim analysis, the study was terminated. The start of the trial was delayed due to data protection issues and the Covid-19 pandemic. Moreover, accrual was slower than expected. Finally, funding has expired. | 2022-12-05 |
| NCT03843554 Terminated | Terminated | Study was terminated with 50% enrollment by the sponsor due to under enrollment into specific diverse racial, ethnic, and sex/gender categories. https://grants.nih.gov/policy/inclusion/women-and-minorities.htm | 2022-08-03 |
| NCT04321850 Terminated | Terminated | Health restrictions due to the COVID-19 pandemic | 2020-07-30 |
| NCT03234465 Terminated | Terminated | No efficacy could be demonstrated, sponsor decided to prematurely end the study. | 2020-07-13 |
| NCT02589860 Withdrawn | Withdrawn | No accrual | 2020-03-23 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: