Oral MucositisPhase 3NCT00574860
EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer
A Phase 3 study testing EN3285 in people with Oral Mucositis and Head and Neck Cancer, run by Endo USA Inc., a Keenova Therapeutics Company at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis, Head and Neck Cancer
- What is being tested?
- EN3285
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Jun 2009
- Phase
- Phase 3
- 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
Significant Inclusion Criteria:
- 18 years and older
- newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
- Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
- Chemotherapy: cisplatin
- Have a WBC ≥3500 per cubic millimeter
- Have a platelet count ≥100,000 per cubic millimeter
- Have adequate renal function as determined by the principal investigator prior to enrollment
- Are willing and able to undergo oral assessments
- Have a Karnofsky Performance Status score ≥70
Significant Exclusion Criteria:
- Have OM or other oral conditions at study entry
- Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
- Are using a pre-existing feeding tube for nutritional support at study entry
- Plan to use any drug for the treatment or prevention of OM
- Have had any prior radiotherapy to the head and neck
- Have had prior chemotherapy within 6 months preceding enrollment
- Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
- Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
- Have medical conditions that require the use of chronic steroid therapy
- Have the inability to undergo repeat treatments,
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Commonwealth ENT
Louisville, Kentucky, 40207
About this study
Official title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy
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).
Read the detailed description
This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) 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). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).
- Conditions
- Oral Mucositis, Head and Neck Cancer
- Being tested
- EN3285, Placebo, Standard of care
- Keywords
- Oral Mucositis, Chemoradiation therapy, Head and neck cancer
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3285Drug
Oral rinse
PlaceboDrug
Oral rinse
Standard of careOther
This will be the therapy most commonly used the the institution treating the patient
| Study group | Role | What they receive |
|---|---|---|
| EN3285 (NAC ProGelz) | Experimental | The EN3285 arm is the product under development Receives: Drug: EN3285 |
| No active ingredients (placebo) | Placebo comparator | This will be an oral product that contains no active ingredient Receives: Drug: Placebo |
| Standard of Care | Other | This arm will reflect the typical standard of care for the patient Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
NCI v3 to measure severity of OM
Measured: At 50 Gy
Secondary outcomes (1)
WHO criteria for measuring severity of OM
Measured: At 50 Gy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Additional research
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Chambers, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574860
- Sponsor's protocol ID
- EN3285-301
- Status last verified
- Sep 2013
- First submitted
- 14 Dec 2007
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT00574860
- Acronym / sponsor ID
- EN3285-301
- Conditions
- Oral Mucositis, Head and Neck Cancer
- Keywords
- Oral Mucositis, Chemoradiation therapy, Head and neck cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Additional research
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Dec 2007 (estimated)
- 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.
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).
Detailed description
This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) 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). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EN3285 (NAC ProGelz) | Experimental | Drug: EN3285The EN3285 arm is the product under development |
| No active ingredients (placebo) | Placebo comparator | Drug: PlaceboThis will be an oral product that contains no active ingredient |
| Standard of Care | Other | Other: Standard of careThis arm will reflect the typical standard of care for the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| EN3285Oral rinse | Drug | EN3285 (NAC ProGelz) |
| PlaceboOral rinse | Drug | No active ingredients (placebo) |
| Standard of careThis will be the therapy most commonly used the the institution treating the patient | Other | Standard of Care |
Primary outcome
NCI v3 to measure severity of OM
Time frame: At 50 Gy
1 secondary outcome
WHO criteria for measuring severity of OM
Time frame: At 50 Gy
Results and safety
The study was stopped early (reason given: Additional research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Mark Chambers, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EN3285 in people with Oral Mucositis and Head and Neck Cancer, run by Endo USA Inc., a Keenova Therapeutics Company 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?
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 20 Sep 2013. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Additional research). 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?
NCI v3 to measure severity of OM (time frame: At 50 Gy). 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 20 Sep 2013.