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Oral MucositisPhase 2NCT01385748

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis

A Phase 2 study testing Clonidine Lauriad® 50µg and Clonidine Lauriad® 100µg in people with Oral Mucositis, run by Valerio Therapeutics at 51 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer. 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?
Clonidine Lauriad® 50µg and Clonidine Lauriad® 100µg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
51 sitesin 6 countries
Study dates
Apr 2010to Dec 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Male or female
  • Aged > 18 years
  • Suffering from a newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx histologically-confirmed and having undergone resective surgery
  • Prior neoadjuvant chemotherapy allowed provided that, the patient did not experience a World Health Organization (WHO) grade > 2 oral mucositis during the neoadjuvant therapy.
  • Patient eligible to receive concurrent chemo-radiation defined as:
  • A continuous course of conventional external beam irradiation (IMRT eligible) with a minimum cumulative radiation dose of 50 Gy or a maximum of 70 Gy, based on a daily dosing between 1.8 and 2.2 Gy combined with platinum based chemotherapy on a weekly or tri-weekly cycles.
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  • Planned radiation treatment fields must include at least two oral tissue sites (among right or left buccal mucosa, floor of mouth, tongue, right or left soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy. The radiation treatment plan will be reviewed by a designated radiation oncologist.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Screening laboratory tests:
  • Haemoglobin ≥ 10g/dL
  • Absolute neutrophil counts ≥ 1500 cells/mm3
  • Platelets ≥ 100.000/mm3
  • Conjugated bilirubin ≤ 2 times Upper Limit of Normal (ULN)
  • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 ULN
  • Negative serum pregnancy test
  • Women of child bearing potential must have effective contraception method (oral or device)
  • Signed written informed consent

Who cannot join

  • Tumours of the lips, sinuses, salivary glands
  • Prior radiation of the head and neck area
  • Curative surgery less than 2 weeks or more than 15 weeks prior to the initiation of radiation therapy-chemotherapy (RT-CT)
  • Presence of active infectious disease
  • Presence of active oral infectious disease, including oropharyngeal candidiasis and/or orofacial herpes
  • Presence of oral mucositis
Show all 20Show fewer
  • Known or suspected chronic viral diseases including HIV
  • Systolic blood pressure < 100 mmHg and/or Diastolic blood pressure < 50 mmHg
  • Recent stroke within the last 6 months
  • Bradyarrhythmia (<60 b/min), including sinus node dysfunction or atrioventricular (AV) nodal conduction block 2nd or 3rd degree
  • Subjects with orthostatic hypotension, defined by a decrease of systolic BP and/or diastolic BP above 20 mmHg when the patient stands up
  • Renal insufficiency (creatinine blood level > 1.5ULN)
  • Ongoing heavy alcohol consumption (>100g alcohol/day)
  • Administration of any concomitant treatment likely to interfere with clonidine
  • Known hypersensitivity to clonidine, history of allergy or intolerance to milk proteins or any other component of the product
  • Presence of severe or uncontrolled depression
  • Pregnant or breast-feeding women
  • Inability to give informed consent or comply with study requirements
  • Unable or unwilling to comply with follow-up visits
  • Participation to a clinical trial within 30 days prior to randomization and during the entire duration of the study

Trial locations and contacts

51 sites in 6 countries.

51 sites in 6 countries

United States19 sites

  • Billings Clinic Montana

    Billings, Montana, 59101

  • Carolinas Medical Center- Carolinas Health Care System

    Charlotte, North Carolina, 28203

  • Compassionate Cancer Care Medical Group

    Corona, California, 92879

  • Centura Health Research Center

    Denver, Colorado, 80210

  • Barbara Ann Karmonos Cancer Hospital

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • University of Connectcut Health Center

    Farmington, Connecticut, 06030

  • California Cancer Associates for Researche and Excellence

    Fresno, California, 93720

  • Penn State Hershey Cancer Institut

    Hershey, Pennsylvania, 17033

  • AMPM Research Clinic

    Miami, Florida, 33145

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Compassionate Cancer Care Medical Group

    Riverside, California, 92501

  • Central Coast Medical Oncology Corp.

    Santa Maria, California, 93454

  • Washington University School of medecine

    St Louis, Missouri, 63110

  • 21st Century Oncology of Arizona

    Sun City, Arizona, 85251

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

France13 sites

  • Hospital Jean Minjoz

    Besançon, 25030

  • CHU Morvan

    Brest, 29000

  • Centre François Baclesse

    Caen, 14000

  • Clinique Pasteur

    Évreux, 27000

  • Centre Oscar Lambret

    Lille, 59000

  • Clinique Chénieux

    Limoges, 87000

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • CH Lyon Sud

    Pierre-Bénite, 69495

  • CHU La Milétrie

    Poitiers, 86000

  • CHP St gregoire

    Saint-Grégoire, 35760

  • Centre de Cancérologie Etienne-Dolet

    Saint-Nazaire, 44600

  • Hôpital Bretonneau

    Tours, 37000

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Spain9 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario de La princesa

    Madrid, 28006

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital 12 de octubre

    Madrid, 28041

  • Hospital Puerta de Hierro Majadahonda

    Madrid, 28222

  • Hospital Universitario Ramon y cajal

    Madrid

  • Hospital Carlos Haya

    Málaga, 29010

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital de Navarra

    Pamplona

Other trials in Spain

Germany5 sites

  • Universitatsklinikum Erlangen Strahlenklinik

    Erlangen, 91054

  • Universitatsklinikum Essen

    Essen, 45147

  • Universitatsklinikum Freiburg Klinik fur Strahlentherapie

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Paracelsius- Klinik

    Osnabrück, 49076

Other trials in Germany

Hungary4 sites

  • Szent Imre Kórház

    Budapest, Tétényi Út 12-16., 1115

  • Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

    Kecskemét, Nyíri U. 38, 6000

  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc, Szentpéteri Kapu 72-76, 3526

  • Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.

    Nyíregyháza, Szent István Út 68, 4400

Other trials in Hungary

Switzerland1 site

  • Centre Hospitalier Universitaire

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad® 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.

Conditions
Oral Mucositis
Being tested
Clonidine Lauriad® 50µg, Clonidine Lauriad® 100µg, Placebo Lauriad®
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clonidine Lauriad® 50µgDrug

    50µg muco-adhesive buccal tablet once day every day up to 8 weeks

  • Clonidine Lauriad® 100µgDrug

    100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks

  • Placebo Lauriad®Drug

    placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks

Study groups in NCT01385748
Study groupRoleWhat they receive
Clonidine Lauriad® 50µgActive comparator50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
Receives: Drug: Clonidine Lauriad® 50µg
Clonidine Lauriad® 100µgActive comparator100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Receives: Drug: Clonidine Lauriad® 100µg
Placebo Lauriad®Placebo comparatorPlacebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Receives: Drug: Placebo Lauriad®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed

    The primary endpoint planned in the protocol was the percentage of participants with an oral mucositis score greater than or equal to 3 using the WHO oral mucositis severity scale at a cumulative radiation dose of 50 Gy. This was modified by protocol amendment to the cumulative radiation dose at which a WHO score greater than or equal to 3 was first observed. This change was made to account for the fact that in real practice most patients receive a cumulative dose between 60 and 70 Gy. The presence of grade 3 or 4 oral mucositis was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = oral ulcers, liquid diet only; WHO score 4 = oral alimentation impossible. Each assessment was associated with the actual cumulative dose of radiotherapy.

    Measured: 8 weeks

Secondary outcomes (4)

  1. At Least One Opioid Use (Class 3 Analgesic)

    Opioid use was recorded twice weekly during the active phase (radiotherapy)

    Measured: 8 weeks

  2. Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)

    Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.

    Measured: 8 weeks

  3. Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)

    Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.

    Measured: 8 weeks

  4. Overall Survival

    After the end-of study visit, the investigator center collects OS follow-up data for each patient who has consented to participate in the follow-up data collection. the OS follow-up period was still ongoing at time of the primary analysis and ended in Nov 2016. The analysis was condicted on the ITT population. The overall survival was evaluate every 6 months after last subject completed in patients who has consented to participate .

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2011 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01385748
Sponsor's protocol ID
BA2009/28/01
Status last verified
Oct 2017
First submitted
29 Jun 2011
Last updated
28 Nov 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clonidine Lauriad® 50µg and Clonidine Lauriad® 100µg in people with Oral Mucositis, run by Valerio Therapeutics at 51 sites in 6 countries.

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 17 inclusion and 20 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: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, France, Spain, Germany, Hungary and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01385748.

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 28 Nov 2017.

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