Oral MucositisPhase 4NCT03490396
Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients
A Phase 4 study testing Gelclair and First® Mouthwash BLM in people with Oral Mucositis, run by Midatech Pharma US Inc. at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Gelclair and First® Mouthwash BLM
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2018to 15 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be age ≥ 18 years old.
- Have Karnofsky performance status score ≥ 70.
- Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in population) followed by allogeneic SCT for hematological malignancy.
- Have anticipated in-patient status for 14 to 20 days from the time of transplant.
- Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
- Be willing and capable of completing the assessments and adhering to protocol requirements.
Show all 9Show fewer
- Be willing and able to provide written informed consent.
- 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.
Who cannot join
- Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than those defined, herein.
- Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
- Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day 1.
- Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
- Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham & Women's Hospital/Dana-Farber Cancer Institute
Boston, Massachusetts, 02120
About this study
Official title: An Adaptive Design, Single-Blind, Randomized, Controlled Study Investigating Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel (Gelclair®) in Comparison to Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash ("Magic Mouthwash") for the Management of Oral Mucositis Associated With High Dose Chemotherapy and Methotrexate in Allogeneic Stem Cell Transplant Recipients
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.
Read the detailed description
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:
- FluBu based regimens: either fludarabine: 30 mg/m^2 x 4 days and busulfan 0.8 mg/kg IV q6h x 4 days; both given daily starting at day -4 OR fludarabine: 40 mg/m^2 and busulfan: 3.2 mg/kg both given daily on days -6 through -3.
- Bu/Cy: busulfan, 0.8 mg/kg IV q6h x 4 days (-7 through -4); cyclophosphamide: 60 mg/kg IV once on days -3 and -2
- Cy/TBI: Cyclophosphamide, 60 mg/kg IV given twice between days -3 and -1 and TBI fractionated (generally over 3 days) for a total of 12Gy
GVHD Prophylaxis:
- Regimens including methotrexate (MTX; 15 mg/m^2 planned to be given on days 1, 3, 6 and 11); addition of other agents given along with MTX (e.g., tacrolimus, sirolimus) is acceptable.
Duration of treatment:
- Arm 1: GEL treatment a minimum of 4x/day initiated from 1st day of conditioning through OM resolution (G0), up to a maximum of 20d.
- Arms 2 (GEL) and 3 (MMW): Treatment a minimum of 4x/day initiated when G1 or G2 OM diagnosed during observation period (through Day +14 relative to stem cell infusion) through OM resolution (G0), up to a maximum of 20d.
- Conditions
- Oral Mucositis
- Being tested
- Gelclair, First® Mouthwash BLM
- Keywords
- Oral Mucositis, Stomatitis, Myeloablative
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelclairDevice
Also called Gelclair Bioadherent Oral Gel
Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel
First® Mouthwash BLMCombination product
Also called Magic Mouth Wash
Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Gelclair at time of conditioning) | Experimental | All subjects in study Arm 1 will receive GEL starting on the first day of conditioning. Receives: Device: Gelclair |
| Arm 2 (Gelclair when OM diagnosed) | Active comparator | 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. Receives: Device: Gelclair |
| Arm 3 (MMW when OM diagnosed) | Active comparator | 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. Receives: Combination Product: First® Mouthwash BLM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Initial study period (initiation of conditioning through day +14 post-transplant)
Area under the curve in mouth and throat soreness (MTS)
Measured: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Secondary outcomes (9)
Time to onset of any grade OM
WHO Grades 1-4
Measured: Initial study period (initiation of conditioning through day +14 post-transplant)
Duration of any grade OM
WHO Grades 1-4
Measured: Study period (initiation of conditioning through day +28 post-transplant)
Severity of OM
WHO Grades 1-4
Measured: Study period (initiation of conditioning through day +28 post-transplant)
Incidence of severe OM
WHO Grades 3-4
Measured: Study period (initiation of conditioning through day +28 post-transplant)
Time to onset of severe OM
WHO Grades 3-4
Measured: Study period (initiation of conditioning through day +28 post-transplant)
Duration of severe OM
WHO Grades 3-4
Measured: 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.
Measured: 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.
Measured: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Opiate and other background pain medication use
Measured: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start15 May 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The initial design is a prospective, randomized, single-blind (evaluator), parallel, three arm, controlled clinical study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midatech Pharma US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharPoint Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Mary Kay Delmedico, PhD, Study director, Midatech Pharma US Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490396
- Sponsor's protocol ID
- GEL-401
- Status last verified
- Nov 2019
- First submitted
- 14 Mar 2018
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Design, Single-Blind, Randomized, Controlled Study Investigating Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel (Gelclair®) in Comparison to Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash ("Magic Mouthwash") for the Management of Oral Mucositis Associated With High Dose Chemotherapy and Methotrexate in Allogeneic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT03490396
- Acronym / sponsor ID
- GEL-401
- Conditions
- Oral Mucositis
- Keywords
- Oral Mucositis, Stomatitis, Myeloablative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Midatech Pharma US Inc.Industry (pharma, biotech, devices)
- Collaborators
- PharPoint Research, Inc.
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- FluBu based regimens: either fludarabine: 30 mg/m^2 x 4 days and busulfan 0.8 mg/kg IV q6h x 4 days; both given daily starting at day -4 OR fludarabine: 40 mg/m^2 and busulfan: 3.2 mg/kg both given daily on days -6 through -3.
- Bu/Cy: busulfan, 0.8 mg/kg IV q6h x 4 days (-7 through -4); cyclophosphamide: 60 mg/kg IV once on days -3 and -2
- Cy/TBI: Cyclophosphamide, 60 mg/kg IV given twice between days -3 and -1 and TBI fractionated (generally over 3 days) for a total of 12Gy
GVHD Prophylaxis:
- Regimens including methotrexate (MTX; 15 mg/m^2 planned to be given on days 1, 3, 6 and 11); addition of other agents given along with MTX (e.g., tacrolimus, sirolimus) is acceptable.
Duration of treatment:
- Arm 1: GEL treatment a minimum of 4x/day initiated from 1st day of conditioning through OM resolution (G0), up to a maximum of 20d.
- Arms 2 (GEL) and 3 (MMW): Treatment a minimum of 4x/day initiated when G1 or G2 OM diagnosed during observation period (through Day +14 relative to stem cell infusion) through OM resolution (G0), up to a maximum of 20d.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The initial design is a prospective, randomized, single-blind (evaluator), parallel, three arm, controlled clinical study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Gelclair at time of conditioning) | Experimental | Device: GelclairAll subjects in study Arm 1 will receive GEL starting on the first day of conditioning. |
| Arm 2 (Gelclair when OM diagnosed) | Active comparator | Device: GelclairSubjects 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. |
| Arm 3 (MMW when OM diagnosed) | Active comparator | Combination Product: First® Mouthwash BLMSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be age ≥ 18 years old.
- Have Karnofsky performance status score ≥ 70.
- Be scheduled to receive one of 3 myeloablative conditioning regimens (defined in population) followed by allogeneic SCT for hematological malignancy.
- Have anticipated in-patient status for 14 to 20 days from the time of transplant.
- Be willing and capable of swishing/gargling oral gel/solution as required per protocol.
Key exclusion criteria (7 listed)
- Subjects receiving pre-transplant conditioning/GVHD prophylaxis regimens other than those defined, herein.
- Use of topical or systemic agents/treatments for OM within 2 weeks of treatment day 1.
- Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (≥ 99.5F /37.5C) requiring systemic anti-infectives, within 7d of treatment Day 1.
- Subjects with active oral lesions or other mouth/throat soreness within 7d of study randomization.
- Any other criteria, in the opinion of the investigator that would make the subject unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GelclairAlso: Gelclair Bioadherent Oral GelPolyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel | Device | Arm 1 (Gelclair at time of conditioning), Arm 2 (Gelclair when OM diagnosed) |
| First® Mouthwash BLMAlso: Magic Mouth WashViscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash | Combination product | Arm 3 (MMW when OM diagnosed) |
Primary outcome
Incidence/occurrence of any grade Oral Mucositis
Time frame: Initial study period (initiation of conditioning through day +14 post-transplant)
Incidence/develop of any grade of OM as assessed via WHO OM grading scale (Grades possible: 1-4)
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)
9 secondary outcomes
Time to onset of any grade OM
Time frame: Initial study period (initiation of conditioning through day +14 post-transplant)
Duration of any grade OM
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Severity of OM
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Incidence of severe OM
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Time to onset of severe OM
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Duration of severe OM
Time frame: Study period (initiation of conditioning through day +28 post-transplant)
Magnitude of OM-related pain control
Time frame: While OM ongoing during study period (initiation of conditioning through day +28 post-transplant)
Duration of pain control
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)
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Kay Delmedico, PhD study director
Midatech Pharma US Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gelclair and First® Mouthwash BLM in people with Oral Mucositis, run by Midatech Pharma US Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence/occurrence of any grade Oral Mucositis (time frame: Initial study period (initiation of conditioning through day +14 post-transplant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.