A Phase 4 interventional study of Gelclair and First® Mouthwash BLM in Oral Mucositis, sponsored by Midatech Pharma US Inc.. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-22.
Sponsored by Midatech Pharma US Inc. · Phase 4, Interventional, and Other
Patients receiving high-dose chemotherapy/conditioning prior to stem cell transplantation (SCT) are at high risk for developing painful lesions in the oral cavity, known as oral mucositis (OM).
In this high risk adult population, the study objectives are to investigate the efficacy and tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a commercially available compounded mouth wash (First® Mouthwash BLM "Magic Mouth Wash"; MMW) initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis and recommendations of the interim data review committee.
Adult patients at high risk for developing OM receiving one of the following myeloablative (MA) pre-transplant conditioning regimens prior to allogeneic transplant along with methotrexate (MTX) as part of graft vs. host disease (GVHD) prophylaxis meeting all other eligibility criteria will be enrolled:
GVHD Prophylaxis:
Duration of treatment:
To be randomized to begin treatment, subjects randomized to Arms 2 or 3 must also meet the following criterion:
-Be diagnosed with G1 or G2 OM via WHO OM scale during observation period from conditioning to Day +14.
Exclusion Criteria:
For subjects randomized to Treatment Arms 2 or 3 during observation period:
-OM ≥ G3 diagnosed prior to initiating randomized treatment during observation period (conditioning through Day +14; i.e., missed treatment window).
All subjects in study Arm 1 will receive GEL starting on the first day of conditioning.
Device: Gelclair
Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive GEL.
Device: Gelclair
Subjects in Arm 2 will be observed from initiation of conditioning to Day +14. If subjects develop G1 or G2 OM via WHO OM scale during this period, they will at that time be randomized to immediately receive MMW.
Combination Product: First® Mouthwash BLM
Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel
Also known as: Gelclair Bioadherent Oral Gel
Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash
Also known as: Magic Mouth Wash
Incidence/occurrence of any grade Oral Mucositis
Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)
Time frame: Initial study period (initiation of conditioning through day +14 post-transplant)
Area under the curve in mouth and throat soreness (MTS)
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Time to onset of any grade OM
WHO Grades 1-4
Time frame: Initial study period (initiation of conditioning through day +14 post-transplant)
Duration of any grade OM
WHO Grades 1-4
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Severity of OM
WHO Grades 1-4
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Incidence of severe OM
WHO Grades 3-4
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Time to onset of severe OM
WHO Grades 3-4
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Duration of severe OM
WHO Grades 3-4
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Magnitude of OM-related pain control
Based on subject grading of mouth and throat soreness (VAS 0 (no pain) to 10 (max pain possible)) prior to each randomized/rescue OM treatment.
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Duration of pain control
Based on time at a given mouth and throat soreness level and/or need for rescue treatment to control mouth and throat soreness.
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Opiate and other background pain medication use
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Weight change over study treatment period
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Incidence of treatment-emergent infection
e.g., bacteremia/febrile neutropenia, including oral infections (e.g., thrush).
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Duration of treatment-emergent infections
e.g., bacteremia/febrile neutropenia, including oral infections (e.g., thrush).
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Use of anti-infectives for treatment-emergent infections
Exploratory Endpoint
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Duration of anti-infective use for treatment-emergent infections
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Dose level of anti-infectives for treatment-emergent infections
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Days of hospitalization post-SCT
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Incidence of need for a modified diet
For example, soft, liquid, TPN
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Duration of need for a modified diet
For example, soft, liquid, TPN
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Treatment Compliance with randomized OM treatment
Assessed by determining the number of randomized treatments actually taken relative to the number of treatments required (i.e., treatment compliance)
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Use of rescue treatments other than randomized agent for managing OM
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Incidence of treatment-emergent xerostomia ≥ G2
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Duration of treatment-emergent xerostomia ≥ G2
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Use of treatments/medications to manage xerostomia
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Duration of use for treatments/medications to manage xerostomia
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Impact of OM on activities of daily living
Via validated oral mucositis daily questionnaire (OMDQ)
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Diarrhea associated with OM
Via validated oral mucositis daily questionnaire (OMDQ)
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Exploratory Safety/Tolerability of GEL and MMW
Assessed by treatment-emergent and related adverse events/serious adverse events/unanticipated adverse device effects and subject reported tolerability.
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Plan to share: No
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