Clinical trials: Stomatitis (Oral Mucositis)
- Condition Stomatitis (Oral Mucositis)
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Oral Mucositis
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients…
- Trial name
- NCT03689712
- Testing
- GC4419 90mg
- Where
- 97 sites in United States, Canada and 1 more
- Volunteers
- 455 people
- Sponsor
- Galera Therapeutics, Inc.
Ebola Virus
Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)
Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola.
- Trial name
- NCT02314923
- Testing
- V920 Vaccine
- Volunteers
- 513 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Oral Mucositis
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length of severe oral mucositis in patients with head and neck cancers.
- Trial name
- PREVLAR (NCT03515538)
- Testing
- RRx-001, Cisplatin for injection, Radiation Therapy
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- EpicentRx, Inc.
Oral Mucositis
Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head…
- Trial name
- NCT03234465
- Testing
- AG013
- Where
- 50 sites in United States, Belgium and 2 more
- Volunteers
- 200 people
- Sponsor
- Oragenics, Inc.
Stomatitis, Oral Mucositis
Efficacy of SNX-1012 in the Treatment of Oral Mucositis
Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck.
- Trial name
- NCT00385515
- Testing
- SNX-1012 (meclocycline sulfosalicylate)
- Where
- 27 sites in United States, India
- Volunteers
- 81 people
- Sponsor
- Mucosal Therapeutics
Oral Mucositis
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy
- Trial name
- NCT01403064
- Testing
- ALD518, 0.9% saline
- Where
- 31 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- CSL Behring
Graft Versus Host Disease, Hematologic Malignancies
Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation
The main purpose of this study is to evaluate the effect of palifermin versus placebo in the reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.
- Trial name
- NCT00189488
- Testing
- Palifermin, Conditioning Regimen, Allogeneic stem cell transplant
- Volunteers
- 155 people
- Sponsor
- Swedish Orphan Biovitrum
Multiple Myeloma
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
The purpose of this study was to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell…
- Trial name
- NCT00434161
- Testing
- Palifermin before only, Palifermin before and after
- Where
- Germany
- Volunteers
- 281 people
- Sponsor
- Swedish Orphan Biovitrum
Oral Mucositis
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
- Trial name
- NCT02013050
- Testing
- SGX942
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Soligenix
Graft vs Host Disease, Congenital Aniridia
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
The ARGOS-IO pressure sensor is intended to be implanted in the human eye in combination with Boston Keratoprosthesis (BKPro) surgery and to remain in place indefinitely.
- Conditions
- Graft vs Host Disease, Congenital Aniridia, Chemical Burns, Stevens-Johnson Syndrome
- Trial name
- NCT02945176
- Testing
- ARGOS-IO system
- Where
- 2 sites in Germany
- Volunteers
- 13 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Cancer, Lymphoma
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization [WHO] grade 3 and 4).
- Conditions
- Cancer, Lymphoma, Leukemia
- Trial name
- NCT00109031
- Testing
- palifermin, Total Body Irradiation, Cyclophosphamide
- Volunteers
- 47 people
- Sponsor
- Swedish Orphan Biovitrum
Oral Herpes Simplex
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.
- Trial name
- NCT01308424
- Testing
- BTL TML HSV
- Where
- 4 sites in United States
- Volunteers
- 171 people
- Sponsor
- Beech Tree Labs, Inc.
Mucositis, Pain
Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
This was an open-label, single-dose study to assess the safety, tolerability, and absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in opioid-tolerant cancer subjects, with or without oral…
- Conditions
- Mucositis, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Trial name
- NCT00956254
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- INSYS Therapeutics Inc
Oral Mucositis
Study to Characterize the Effect of Heparin on Palifermin Activity
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.
- Trial name
- NCT01163097
- Testing
- Palifermin, Heparin
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Ebola Viruses
Safety and Immunogenicity of Prime-Boost Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-002)
Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus (ZEBOV) has affected several thousand people. There is no approved effective way to treat or prevent Ebola.
- Trial name
- NCT02280408
- Testing
- V920
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Oral Mucositis
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.
- Trial name
- NCT01385748
- Testing
- Clonidine Lauriad® 50µg, Clonidine Lauriad® 100µg
- Where
- 51 sites in United States, France and 4 more
- Volunteers
- 183 people
- Sponsor
- Valerio Therapeutics
Leukemia
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation [TBI]) followed by hematopoietic stem cell…
- Trial name
- NCT00460421
- Testing
- Palifermin, Total Body irradiation, Chemotherapy
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Swedish Orphan Biovitrum
Radiation Induced Oral Mucositis
A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in…
- Trial name
- NCT02508389
- Testing
- Low Dose GC4419: 30mg/day, High Dose GC4419: 90mg/day, Intensity-Modulated Radiation Therapy
- Where
- 64 sites in United States, Canada and 1 more
- Volunteers
- 223 people
- Sponsor
- Galera Therapeutics, Inc.
Advanced Breast Cancer
Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer
Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer
- Trial name
- NCT02069093
- Testing
- Dexamethasone based mouthwash, Everolimus, Exemestane
- Where
- 23 sites in United States
- Volunteers
- 92 people
- Sponsor
- Novartis Pharmaceuticals
Head and Neck Neoplasms, Mucositis
Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation regimens used to treat cancer. This study examines the investigational drug brilacidin and its possible application in prevention of oral…
- Trial name
- Brilacidin (NCT02324335)
- Testing
- Brilacidin
- Where
- 16 sites in United States
- Volunteers
- 61 people
- Sponsor
- Innovation Pharmaceuticals, Inc.