Clinical trials: Oral Mucositis
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.
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
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.
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.
Oral Herpes Simplex
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.
- Trial name
- NCT01902303
- Testing
- BTL-TML-HSV
- Where
- 3 sites in United States
- Volunteers
- 303 people
- Sponsor
- Beech Tree Labs, Inc.
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
Head and Neck Cancer
A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer
This is a Phase 1 / Phase 2 study of newly diagnosed patients with biopsy-proven head and neck cancer (squamous cell carcinoma) who are undergoing standard radiation therapy and treatment with cisplatin.
- Trial name
- BMX-HN (NCT02990468)
- Testing
- BMX-001, Radiation Therapy, Cisplatin
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- BioMimetix JV, LLC
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.
Mucositis, Head and Neck Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy
Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting
- Trial name
- NCT00626639
- Testing
- palifermin, Radiotherapy, Cisplatin
- Volunteers
- 5 people
- Sponsor
- Swedish Orphan Biovitrum
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
Oral Mucositis
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis
The initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse…
- Trial name
- NCT02399228
- Testing
- 0.25% EISO mouth rinse
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Santalis Pharmaceuticals, 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
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
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.
Mucositis, Solid Tumors
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity…
- Conditions
- Mucositis, Solid Tumors, Stomatitis, Head and Neck Cancer
- Trial name
- NCT00101582
- Testing
- palifermin, cisplatin chemotherapy, Radiotherapy
- Volunteers
- 188 people
- Sponsor
- Swedish Orphan Biovitrum
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
A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis
To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT).
- Trial name
- episil(R) (NCT01684566)
- Testing
- episil(R), Oral hygiene procedures
- Where
- 12 sites in Germany, Israel and 2 more
- Volunteers
- 116 people
- Sponsor
- Camurus AB
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
Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, Oral Mucositis
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
- Trial name
- NCT03237325
- Testing
- SGX942
- Where
- 53 sites in United States, Belgium and 3 more
- Volunteers
- 266 people
- Sponsor
- Soligenix