Clinical trials: Mucosal Inflammation
Stomatitis
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy
- Trial name
- NCT01099891
- Testing
- rhEGF
- Where
- 2 sites in South Korea
- Volunteers
- 300 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Cord Blood Transplant, Hematologic Malignancy
Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Pediatric Patients Undergoing Single or Double Umbilical Cord Blood Transplantation
Engraftment failure is a major obstacle to the success of cord blood transplantation in children with malignancies and inherited metabolic disorders, despite the fact that they receive relatively high doses of nucleated cells…
- Conditions
- Cord Blood Transplant, Hematologic Malignancy, Inherited Metabolic Disease
- Trial name
- NCT01554254
- Testing
- TXA127
- Where
- United States
- Sponsor
- Tarix Pharmaceuticals
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.
Head & Neck Cancer, Oral Mucositis
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.
Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain.
- Trial name
- BEAM-Pain (NCT07672236)
- Testing
- BupiZenge 25 mg, Lidocaine viscous 2%
- Where
- 11 sites in Denmark, Germany and 2 more
- Volunteers
- 150 people
- Sponsor
- OncoZenge AB
Radiation-induced Oral Mucositis
Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer
Oral mucositis (OM) is an acute side effect of radiotherapy for head and neck cancer (HNC). OM associated pain affects oral functions and nutrition of the patient that may result in discontinuity of treatment.The purpose of this…
- Trial name
- NCT04204382
- Testing
- Levofloxacin Injection, Compound Kushen Injection（CKI）
- Where
- 12 sites in China
- Volunteers
- 144 people
- Sponsor
- Shanxi Zhendong Pharmacy Co., Ltd
Hematologic Malignancies
Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation
The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double umbilical cord blood transplantation (UCBT).
- Trial name
- NCT01882374
- Testing
- TXA127
- Where
- United States
- Sponsor
- Tarix Pharmaceuticals
Head and Neck Cancer
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and…
- Trial name
- NCT00131638
- Testing
- Palifermin
- Volunteers
- 241 people
- Sponsor
- Amgen
Oral Mucositis, Nausea
ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial
RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an effective single therapy approach for the management of chemoradiation mucositis, treating and preventing its occurrence in the oral cavity…
- Conditions
- Oral Mucositis, Nausea, Vomiting, Diarrhea
- Trial name
- NCT02016807
- Testing
- ProThelial
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Ashley Downs Bioscience
Oral Mucositis Due to Radiation, Radiation Dermatitis
Feasibility and Safety of CareMin650 in Patients at Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis…
- Trial name
- SafePBM (NCT03988556)
- Testing
- Photobiomodulation using CareMin650 at 6 Joules (curative intent), Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)
- Where
- 5 sites in France
- Volunteers
- 72 people
- Sponsor
- NeoMedLight
Chemotherapy Induced Mucositis, Mouth Pain
A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain
The purpose of this study is to characterize the pharmacokinetics and tolerability of buprenorphine patches in children who require opioid pain relief for moderate to severe mouth pain.
- Trial name
- BUP1501 (NCT00947466)
- Testing
- Buprenorphine
- Where
- 2 sites in Denmark, United Kingdom
- Volunteers
- 25 people
- Sponsor
- Mundipharma Research Limited
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
Oral Mucositis, Stem Cell Transplant Complications
Study of a New Medical Device for Oral Mucositis
This is a single-center randomized controlled trial of a new medical device (Bocaliner™) that has been designed to improve the treatment of chemotherapy-induced oral mucositis in patients undergoing cancer treatment.
- Trial name
- MDOM (NCT05104268)
- Testing
- Bocaliner
- Where
- Armenia
- Sponsor
- E2Bio Life Sciences, LLC
Ulcerative Colitis
Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis
Ulcerative colitis is characterized by abnormal activation of, and damage to, the colon epithelium, which is considered to be a central pathogenic mechanism.
- Trial name
- NCT00727324
- Testing
- bovine intestinal alkaline phosphatase (BIAP)
- Where
- 11 sites in Czechia, Italy
- Volunteers
- 22 people
- Sponsor
- AM-Pharma
Stomatitis, Radiation Effects
Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx
The purpose of this study is to compare the effectiveness and safety of benzydamine hydrochloride 0.15% oral rinse to a vehicle oral rinse in the treatment of radiation-induced oral mucositis, and to compare the care normally…
- Trial name
- NCT00051441
- Testing
- Benzydamine Hydrochloride 0.15% Oral Rinse
- Volunteers
- 605 people
- Sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Oral Mucositis, Lymphoma
Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT
Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell…
- Conditions
- Oral Mucositis, Lymphoma, Multiple Myeloma, Hematologic Cancer
- Trial name
- Capella (NCT05493800)
- Testing
- MIT-001, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- MitoImmune Therapeutics
Lymphoma, Non-Hodgkin's, Adult, Lymphoma, Hodgkin's, Adult
Safety, Tolerability, PK/PD of FE 203799 in Adults With Lymphomas
RATIONALE: The integrity of the intestinal mucosa is a key factor for the preservation of a normal gut function. Damage of the epithelium (i.e.
- Trial name
- NCT03417765
- Testing
- FE 203799
- Sponsor
- GlyPharma Therapeutics
Common Cold, Nasal Mucosal Inflammation
Post Market Clinical Follow-Up Study - Medical Device KalobaNaso
The goal of this observational PMCF study is to confirm the efficacy and safety of the medical device KalobaNaso (a nasal spray) in children, adolescents and adults with common cold symptoms, such as runny nose, nasal congestion…
- Conditions
- Common Cold, Nasal Mucosal Inflammation, Rhinitis
- Trial name
- PMCF (NCT05960318)
- Testing
- KalobaNaso spray, KalobaNaso junior spray
- Where
- Italy
- Volunteers
- 131 people
- Sponsor
- Schwabe Pharma Italia
Mucositis
Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690
Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate.
- Trial name
- TK112690 (NCT04046250)
- Testing
- TK-112690
- Where
- 3 sites in India
- Volunteers
- 22 people
- Sponsor
- Tosk, Inc.
Non-Small Cell Lung Cancer
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®
To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.
- Trial name
- NCT01820091
- Testing
- Folotyn, Fusilev
- Sponsor
- Acrotech Biopharma Inc.
Mucositis
Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690
Patients expected to receive a 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer.
- Trial name
- NCT05669521
- Testing
- TK-112690
- Where
- 5 sites in India
- Volunteers
- 24 people
- Sponsor
- Tosk, Inc.