Clinical trials: Mucosal Inflammation
Head and Neck Cancer, Oral Mucositis
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.
- Trial name
- NCT00790322
- Testing
- SBG
- Where
- France
- Volunteers
- 130 people
- Sponsor
- Biotec Pharmacon ASA
Oral Mucositis
Study for the Prevention of Oral Mucositis (SPOM)
1. Study Design Prospective, Randomized, Questionnaire-Based Study Study Type: Phase 1/Phase 2 Interventional Clinical Trial Intervention Model: Parallel Assignment Masking: None (Open-label) Actual Enrollment: 100 participants…
- Trial name
- SPOM (NCT05338398)
- Testing
- Bocaliner, Benzydamine
- Where
- Armenia
- Volunteers
- 100 people
- Sponsor
- E2Bio Life Sciences, LLC
Head and Neck Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy
The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.
- Trial name
- NCT00540332
- Testing
- palifermin
- Sponsor
- Swedish Orphan Biovitrum
Crohn's Disease
Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy
The purpose of this study is to evaluate safety, tolerability, and effect on mucosal repair of AZD7798 compared with placebo in participants with active ileal Crohn's disease and an ileostomy.
- Trial name
- CALLISTO (NCT06681324)
- Testing
- AZD7798
- Where
- 17 sites in Belgium, Italy and 5 more
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Post-surgical Oral Wounds, Oral Cavity Surgery
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of…
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites
- Trial name
- PR-DENT (NCT07421934)
- Testing
- Intervention: Linear Hyaluronic Acid (Gumblast), Control: Standard Surgical Procedure
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- The Wave Innovation Group s.r.l.
Oral Mucositis
Study of Dentoxol® Mouthrinse for Oral Mucositis
The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.
- Trial name
- NCT02885376
- Testing
- Dentoxol
- Where
- 3 sites in Chile
- Volunteers
- 108 people
- Sponsor
- Ingalfarma SpA
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.
Leukemia, Lymphoma
Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support.
- Conditions
- Leukemia, Lymphoma, Myeloma
- Trial name
- NCT00070616
- Testing
- Palifermin 6 x 60 μg/kg/day, Palifermin 2 x 180 μg/kg/day, radiotherapy
- Volunteers
- 25 people
- Sponsor
- Swedish Orphan Biovitrum
Head and Neck Squamous Cell Carcinoma, Oral Mucositis
MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
The proposed study in patients with previously untreated locally advanced head and neck squamous cell carcinoma (HNSCC) is designed to evaluate the efficacy and safety of three different doses of MIT-001 compared to the placebo…
- Trial name
- MIT-001 (NCT04651634)
- Testing
- MIT-001 plus CCRT
- Where
- 16 sites in United States, South Korea
- Volunteers
- 60 people
- Sponsor
- MitoImmune Therapeutics
Oral Mucositis, Quality of Life
Retrospective Observational Study of Oral Complications and Quality of Life in Head and Neck Cancer Patients Treated With Radiotherapy or Chemoradiotherapy.
Head and Neck cancer patients receiving radiation therapy (with or without chemotherapy) suffer several oral complications, such as oral mucositis, which impairs quality of life of patients during radiotherapy and in the…
- Conditions
- Oral Mucositis, Quality of Life, Mucositis, Pain
- Trial name
- NCT07739771
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- Mucosa Innovations, S.L.
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.
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and…
- Trial name
- NCT01921426
- Testing
- GC4419
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Galera Therapeutics, Inc.
Colon Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer
The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3…
- Trial name
- NCT00393822
- Testing
- palifermin
- Volunteers
- 100 people
- Sponsor
- Amgen
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
Radiation Induced Mucositis in Head and Neck Cancer
A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Trial name
- NCT01903018
- Testing
- P276-00, Radiation Therapy, Cisplatin
- Where
- 7 sites in India
- Volunteers
- 73 people
- Sponsor
- Piramal Enterprises Limited
Oral Mucositis
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy…
- Trial name
- NCT01400620
- Testing
- IZN-6N4
- Where
- 10 sites in United States, Israel
- Volunteers
- 110 people
- Sponsor
- Izun Pharma Ltd
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
Mucositis, Nephrotoxicity
Treatment of Radiation and Cisplatin Induced Toxicities with Tempol
A 10 week trial to assess the ability of Tempol to prevent and/or reduce toxicities associated with cisplatin and radiation treatment in head and neck cancer patients.
- Conditions
- Mucositis, Nephrotoxicity, Ototoxicity
- Trial name
- NCT03480971
- Testing
- Tempol
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Matrix Biomed, Inc.
Oral Mucositis
Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck
The purpose of this study is to assess the safety and tolerability of AG013 (genetically modified L. lactis bacteria engineered to secrete human Trefoil Factor 1), and to explore the ability of AG013 to attenuate the course and…
- Trial name
- NCT00938080
- Testing
- AG013
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- ActoGeniX N.V.
Oral Mucositis, Head and Neck Cancer
EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer
Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).
- Trial name
- NCT00574860
- Testing
- EN3285, Standard of care
- Where
- 2 sites in United States
- Volunteers
- 240 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company