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43 Mechanisms of Action |
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- Enrollment change: A Study to Characterize the Pharmacokinetics and Tolerability of Buprenorphine Patches in Children With Moderate to Severe Mouth Pain (clinicaltrials.gov) - Sep 28, 2015
P1/2, N=25, Terminated, Sponsor: Mundipharma Research Limited
N=60 --> 25
- Trial completion: Herbal Mouthrinse for Oral Mucositis Study (clinicaltrials.gov) - Sep 24, 2015
P2, N=50, Completed, Sponsor: Medical University of South Carolina
N=60 --> 25 Active, not recruiting --> Completed
- ||| dusquetide (SGX942) / Soligenix
Enrollment closed: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Sep 22, 2015
P2, N=78, Active, not recruiting, Sponsor: Soligenix
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- doxorubicin hydrochloride / Generic mfg.
Enrollment change: Curcumin for Prevention of Oral Mucositis in Children Chemotherapy (clinicaltrials.gov) - Aug 19, 2015
P3, N=8, Completed, Sponsor: Hadassah Medical Organization
Recruiting --> Active, not recruiting N=10 --> 8
- Omegaven (omega-3 long-chain polyunsaturated fatty acids) / Fresenius Kabi
Trial completion, Enrollment change: LUNCH1: Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (clinicaltrials.gov) - Aug 13, 2015
P2, N=14, Completed, Sponsor: University Hospital Inselspital, Berne
N=10 --> 8 Suspended --> Completed | N=35 --> 14
- | Trial initiation date, Trial primary completion date: A Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - Aug 11, 2015
P3, N=108, Not yet recruiting, Sponsor: All India Institute of Medical Sciences, New Delhi
Suspended --> Completed | N=35 --> 14 Initiation date: Mar 2013 --> Nov 2015 | Trial primary completion date: Dec 2014 --> Oct 2016
- avasopasem manganese (GC4419) / Galera Therap
Enrollment closed, Combination therapy: A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck (clinicaltrials.gov) - Jul 20, 2015
P1, N=30, Active, not recruiting, Sponsor: Galera Therapeutics, Inc.
Initiation date: Mar 2013 --> Nov 2015 | Trial primary completion date: Dec 2014 --> Oct 2016 Recruiting --> Active, not recruiting
- | Enrollment closed, Trial primary completion date: CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy (clinicaltrials.gov) - Jul 10, 2015
P3, N=148, Active, not recruiting, Sponsor: Alliance for Clinical Trials in Oncology
Recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting | Trial primary completion date: Jul 2013 --> Dec 2017
- acetylcysteine solution / Generic mfg.
Trial primary completion date: Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy (clinicaltrials.gov) - Jun 25, 2015
P=N/A, N=36, Recruiting, Sponsor: Mayo Clinic
Not yet recruiting --> Active, not recruiting | Trial primary completion date: Jul 2013 --> Dec 2017 Trial primary completion date: Apr 2015 --> Apr 2018
- || dusquetide (SGX942) / Soligenix
Trial primary completion date: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Jun 11, 2015
P2, N=78, Recruiting, Sponsor: Soligenix
Trial primary completion date: Apr 2015 --> Apr 2018 Trial primary completion date: Dec 2014 --> Oct 2015
- methotrexate IV / Generic mfg.
Trial termination, Trial primary completion date, Adverse events: Will Glucarpidase After Methotrexate Treatment for Bone Sarcoma Lead to Fewer Side Effects and Reduce Chemotherapy Delays? (clinicaltrials.gov) - Jun 11, 2015
P2, N=34, Terminated, Sponsor: University College, London
Trial primary completion date: Dec 2014 --> Oct 2015 Recruiting --> Terminated | Trial primary completion date: Dec 2014 --> Jun 2015; Recruitment almost complete, has been slow and challenging
- Sativex (nabiximols) / Jazz
Enrollment change, Trial termination, Trial primary completion date: A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis (clinicaltrials.gov) - Jun 11, 2015
P1, N=10, Terminated, Sponsor: GW Pharmaceuticals Ltd.
Recruiting --> Terminated | Trial primary completion date: Dec 2014 --> Jun 2015; Recruitment almost complete, has been slow and challenging N=24 --> 10 | Recruiting --> Terminated | Trial primary completion date: Nov 2014 --> May 2015; Slow recruitment
- |||| brilacidin (PMX-30063) / Innovation Pharma
Enrollment open: Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - May 27, 2015
P2, N=60, Recruiting, Sponsor: Cellceutix Corporation
N=24 --> 10 | Recruiting --> Terminated | Trial primary completion date: Nov 2014 --> May 2015; Slow recruitment Not yet recruiting --> Recruiting
- Trial primary completion date: Local Anesthetic Treatment of Oral Pain in Patients With Mucositis (clinicaltrials.gov) - Apr 28, 2015
P2, N=40, Recruiting, Sponsor: Hvidovre University Hospital
Not yet recruiting --> Recruiting Trial primary completion date: Jan 2015 --> Aug 2015
- | NN1213 / Novo Nordisk
Trial completion: Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation (clinicaltrials.gov) - Apr 28, 2015
P=N/A, N=0, Completed, Sponsor: National Cancer Institute (NCI)
Trial primary completion date: Jan 2015 --> Aug 2015 Recruiting --> Completed
- Trial primary completion date: Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer (clinicaltrials.gov) - Apr 22, 2015
P2, N=10, Recruiting, Sponsor: Dartmouth-Hitchcock Medical Center
Recruiting --> Completed Trial primary completion date: Jan 2015 --> Jan 2016
- Trial primary completion date: ROSAM: Role of SAMITAL (clinicaltrials.gov) - Apr 19, 2015
P2, N=120, Recruiting, Sponsor: Istituto Oncologico Veneto IRCCS
Trial primary completion date: Jan 2015 --> Jan 2016 Trial primary completion date: Jun 2015 --> Oct 2016
- melphalan / Generic mfg.
Trial completion, Trial primary completion date: Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients (clinicaltrials.gov) - Apr 2, 2015
P2, N=148, Completed, Sponsor: Ohio State University Comprehensive Cancer Center
Trial primary completion date: Jun 2015 --> Oct 2016 Active, not recruiting --> Completed | Trial primary completion date: Apr 2015 --> May 2014
- Humira (adalimumab) / AbbVie
Enrollment change: ADACAL: Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants (clinicaltrials.gov) - Mar 17, 2015
P3, N=15, Terminated, Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Active, not recruiting --> Completed | Trial primary completion date: Apr 2015 --> May 2014 N=160 --> 15
- melphalan / Generic mfg.
Enrollment open: Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant (clinicaltrials.gov) - Mar 17, 2015
P1/2, N=48, Recruiting, Sponsor: University of Florida
N=160 --> 15 Not yet recruiting --> Recruiting
- Trial completion: CP073: Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis (clinicaltrials.gov) - Mar 17, 2015
P=N/A, N=33, Completed, Sponsor: Grupo de Investigaci
Not yet recruiting --> Recruiting Recruiting --> Completed
- melphalan / Generic mfg.
Trial completion, Enrollment change: Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - Mar 17, 2015
P=N/A, N=117, Completed, Sponsor: The University of Texas Health Science Center at San Antonio
Recruiting --> Completed Recruiting --> Completed | N=165 --> 117
- ||||||| Kepivance (palifermin) / SOBI, Amgen
Trial completion: A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma (clinicaltrials.gov) - Mar 10, 2015
P3, N=281, Completed, Sponsor: Swedish Orphan Biovitrum
Recruiting --> Completed | N=165 --> 117 Active, not recruiting --> Completed
- Zyclara (imiquimod) / Mochida, Viatris, Bausch Health
Biomarker, Enrollment change: Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation (clinicaltrials.gov) - Feb 5, 2015
P2, N=20, Completed, Sponsor: CONRAD
Active, not recruiting --> Completed N=39 --> 20
- Validive (clonidine MBT) / Monopar Therap
Trial completion: Efficacy and Safety Study of Clonidine Lauriad (clinicaltrials.gov) - Feb 5, 2015
P2, N=183, Completed, Sponsor: Onxeo
N=39 --> 20 Recruiting --> Completed
- |||| Easyef (nepidermin) / Daewoong Pharma
Trial completion: EGFOM: Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies (clinicaltrials.gov) - Jan 22, 2015
P2, N=138, Completed, Sponsor: Seoul National University Hospital
Recruiting --> Completed Recruiting --> Completed
- melphalan / Generic mfg.
New P1/2 trial: Cryotherapy in the Prevention of Chemotherapy-Induced Mucositis in Stem Cell Transplant (clinicaltrials.gov) - Dec 29, 2014
P1/2, N=48, Not yet recruiting, Sponsor: University of Florida
- ||||| brilacidin (PMX-30063) / Innovation Pharma
New P2 trial: Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Dec 25, 2014
P2, N=60, Not yet recruiting, Sponsor: Cellceutix Corporation
- || Trial primary completion date: Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer (clinicaltrials.gov) - Dec 10, 2014
P2, N=110, Recruiting, Sponsor: Izun Pharma Ltd
Recruiting --> Completed Trial primary completion date: Mar 2014 --> Jun 2016
- Enrollment closed: Experimental Peri-implant Mucositis in Humans (clinicaltrials.gov) - Dec 6, 2014
P=N/A, N=15, Active, not recruiting, Sponsor: University of Connecticut Health Center
Trial primary completion date: Mar 2014 --> Jun 2016 Recruiting --> Active, not recruiting
- Trial primary completion date: Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - Dec 5, 2014
P=N/A, N=50, Recruiting, Sponsor: Uppsala University
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2014 --> Jun 2015
- oxycodone controlled release / Generic mfg.
Clinical data: Early Use of Opioid in Radiation Mucositis (clinicaltrials.gov) - Dec 5, 2014
P=N/A, N=174, Not yet recruiting, Sponsor: Affiliated Tumor Hospital of Guangzhou Medical University
- Enrollment closed, Trial primary completion date: Herbal Mouthrinse for Oral Mucositis Study (clinicaltrials.gov) - Dec 5, 2014
P2, N=50, Active, not recruiting, Sponsor: Medical University of South Carolina
Trial primary completion date: Jan 2014 --> Jun 2015 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2014 --> Jun 2015
- | everolimus / Generic mfg.
Enrollment open: Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer (clinicaltrials.gov) - Nov 5, 2014
P2, N=26, Recruiting, Sponsor: Emory University
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2014 --> Jun 2015 Not yet recruiting --> Recruiting
- | everolimus / Generic mfg.
New P2 trial: Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer (clinicaltrials.gov) - Oct 24, 2014
P2, N=26, Not yet recruiting, Sponsor: Emory University
- Biomarker, Trial completion, Enrollment change, Trial primary completion date, HEOR: Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients (clinicaltrials.gov) - Oct 23, 2014
P2, N=24, Completed, Sponsor: University of California, San Francisco
Not yet recruiting --> Recruiting Recruiting --> Completed | N=20 --> 24 | Trial primary completion date: Apr 2015 --> Aug 2014
- Trial initiation date, Trial suspension, Trial primary completion date: Honey in Chronic Immune Thrombocytopenia (clinicaltrials.gov) - Oct 22, 2014
P2, N=30, Suspended, Sponsor: mamdouh abdulmaksoud abdulrhman
Recruiting --> Completed | N=20 --> 24 | Trial primary completion date: Apr 2015 --> Aug 2014 Initiation date: Jan 2012 --> Oct 2014 | Not yet recruiting --> Suspended | Trial primary completion date: Jun 2012 --> Nov 2014
- Enrollment open: Local Anesthetic Treatment of Oral Pain in Patients With Mucositis (clinicaltrials.gov) - Oct 17, 2014
P2, N=40, Recruiting, Sponsor: Hvidovre University Hospital
Initiation date: Jan 2012 --> Oct 2014 | Not yet recruiting --> Suspended | Trial primary completion date: Jun 2012 --> Nov 2014 Not yet recruiting --> Recruiting
- Enrollment closed: Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients (clinicaltrials.gov) - Oct 17, 2014
P=N/A, N=12, Active, not recruiting, Sponsor: Dana-Farber Cancer Institute
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- Trial completion, Enrollment change, Trial primary completion date: The Effect of Honey on Xerostomia and Oral Mucositis (clinicaltrials.gov) - Oct 10, 2014
P2, N=72, Completed, Sponsor: Cyprus University of Technology
Recruiting --> Active, not recruiting Recruiting --> Completed | N=60 --> 72 | Trial primary completion date: Jan 2013 --> Sep 2014
- New P2 trial: Local Anesthetic Treatment of Oral Pain in Patients With Mucositis (clinicaltrials.gov) - Sep 30, 2014
P2, N=40, Not yet recruiting, Sponsor: Hvidovre University Hospital
- avasopasem manganese (GC4419) / Galera Therap
Trial primary completion date, Combination therapy: A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck (clinicaltrials.gov) - Sep 19, 2014
P1, N=30, Recruiting, Sponsor: Galera Therapeutics, Inc.
Recruiting --> Completed | N=60 --> 72 | Trial primary completion date: Jan 2013 --> Sep 2014 Trial primary completion date: Jun 2014 --> Jun 2015
- |||| Kepivance (palifermin) / SOBI, Amgen
Trial completion, Trial initiation date: 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 (clinicaltrials.gov) - Sep 15, 2014
P2, N=155, Completed, Sponsor: Swedish Orphan Biovitrum
Trial primary completion date: Jun 2014 --> Jun 2015 Active, not recruiting --> Completed | Initiation date: Aug 2005 --> Dec 2005
- Trial primary completion date: Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer (clinicaltrials.gov) - Sep 8, 2014
P2, N=10, Recruiting, Sponsor: Dartmouth-Hitchcock Medical Center
Active, not recruiting --> Completed | Initiation date: Aug 2005 --> Dec 2005 Trial primary completion date: Jun 2014 --> Jan 2015
- |||| riviciclib (P27600) / Piramal Phytocare
Trial completion, Phase classification, Trial primary completion date, Metastases: A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00 (clinicaltrials.gov) - Sep 5, 2014
P2, N=73, Completed, Sponsor: Piramal Enterprises Limited
Trial primary completion date: Jun 2014 --> Jan 2015 Active, not recruiting --> Completed | Phase classification: P2/3 --> P2 | Trial primary completion date: Jun 2015 --> Mar 2014
- || Easyef (nepidermin) / Daewoong Pharma
Trial primary completion date: EGFOM: Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies (clinicaltrials.gov) - Aug 25, 2014
P2, N=138, Recruiting, Sponsor: Seoul National University Hospital
Active, not recruiting --> Completed | Phase classification: P2/3 --> P2 | Trial primary completion date: Jun 2015 --> Mar 2014 Trial primary completion date: Feb 2012 --> Sep 2014
- selenomethionine (SLM) / University of Iowa, Holden Comprehensive Cancer Center
Trial termination, Metastases: Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy (clinicaltrials.gov) - Aug 22, 2014
P2, N=18, Terminated, Sponsor: Roswell Park Cancer Institute
Trial primary completion date: Feb 2012 --> Sep 2014 Completed --> Terminated; Due to a lack of funding
- Trial completion, Adverse events: Acute and Longlasting Side Effects Caused by Radiotherapy in the Head and Neck Area (clinicaltrials.gov) - Aug 15, 2014
P=N/A, N=58, Completed, Sponsor: Norwegian University of Science and Technology
Completed --> Terminated; Due to a lack of funding Active, not recruiting --> Completed
- ||||||| Kepivance (palifermin) / SOBI, Amgen
Trial completion, Metastases: A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer (clinicaltrials.gov) - Jul 15, 2014
P2/3, N=100, Completed, Sponsor: Amgen
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || Trial primary completion date: Efficacy of MUCIPLIQ on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering From Oral Cancer (clinicaltrials.gov) - May 14, 2014
P=N/A, N=105, Recruiting, Sponsor: Organ, Tissue, Regeneration, Repair and Replacement
Active, not recruiting --> Completed Trial primary completion date: Feb 2014 --> May 2015