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

NCT01385748 | Completed Phase 2 Results

• 1 other identifier: BA2009/28/01
• Study Type: interventional
• Target: 183
• Locations: 6 countries
• Sites: 51

Brief 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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (4)

• At Least One Opioid Use (Class 3 Analgesic)

  8 weeks

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

  8 weeks

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

  8 weeks

• Overall Survival

  2 years

Other Outcomes (5)

• Time to Onset of Severe Oral Mucositis

  8 weeks

• The Maximum Severity of Oral Mucositis

  8 weeks

• The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.

  8 weeks

Study Arms (3)

Clonidine Lauriad® 50µg

ACTIVE COMPARATOR

50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks

Drug: Clonidine Lauriad® 50µg

Clonidine Lauriad® 100µg

ACTIVE COMPARATOR

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

Drug: Clonidine Lauriad® 100µg

Placebo Lauriad®

PLACEBO COMPARATOR

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

Drug: Placebo Lauriad®

Interventions

Clonidine Lauriad® 50µg DRUG

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

Clonidine Lauriad® 50µg

Clonidine Lauriad® 100µg DRUG

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

Clonidine Lauriad® 100µg

Placebo Lauriad® DRUG

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

Placebo Lauriad®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Valerio Therapeutics: lead

Study Sites (51)

21st Century Oncology of Arizona

Sun City, Arizona, 85251, United States

Location

Compassionate Cancer Care Medical Group

Corona, California, 92879, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

California Cancer Associates for Researche and Excellence

Fresno, California, 93720, United States

Location

Compassionate Cancer Care Medical Group

Riverside, California, 92501, United States

Location

Central Coast Medical Oncology Corp.

Santa Maria, California, 93454, United States

Location

Centura Health Research Center

Denver, Colorado, 80210, United States

Location

University of Connectcut Health Center

Farmington, Connecticut, 06030, United States

Location

AMPM Research Clinic

Miami, Florida, 33145, United States

Location

Barbara Ann Karmonos Cancer Hospital

Detroit, Michigan, 48201, United States

Location

Washington University School of medecine

St Louis, Missouri, 63110, United States

Location

Billings Clinic Montana

Billings, Montana, 59101, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Carolinas Medical Center- Carolinas Health Care System

Charlotte, North Carolina, 28203, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Penn State Hershey Cancer Institut

Hershey, Pennsylvania, 17033, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Hospital Jean Minjoz

Besançon, 25030, France

Location

CHU Morvan

Brest, 29000, France

Location

Centre François Baclesse

Caen, 14000, France

Location

Clinique Pasteur

Évreux, 27000, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Clinique Chénieux

Limoges, 87000, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

CH Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU La Milétrie

Poitiers, 86000, France

Location

CHP St gregoire

Saint-Grégoire, 35760, France

Location

Centre de Cancérologie Etienne-Dolet

Saint-Nazaire, 44600, France

Location

Hôpital Bretonneau

Tours, 37000, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Universitatsklinikum Erlangen Strahlenklinik

Erlangen, 91054, Germany

Location

Universitatsklinikum Essen

Essen, 45147, Germany

Location

Universitatsklinikum Freiburg Klinik fur Strahlentherapie

Freiburg im Breisgau, 79106, Germany

Location

Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Paracelsius- Klinik

Osnabrück, 49076, Germany

Location

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

Kecskemét, Nyíri U. 38, 6000, Hungary

Location

Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.

Nyíregyháza, Szent István Út 68, 4400, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

Miskolc, Szentpéteri Kapu 72-76, 3526, Hungary

Location

Szent Imre Kórház

Budapest, Tétényi Út 12-16., 1115, Hungary

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de La princesa

Madrid, 28006, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 de octubre

Madrid, 28041, Spain

Location

Hospital Puerta de Hierro Majadahonda

Madrid, 28222, Spain

Location

Hospital Universitario Ramon y cajal

Madrid, Spain

Location

Hospital Carlos Haya

Málaga, 29010, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital de Navarra

Pamplona, Spain

Location

Centre Hospitalier Universitaire

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Berangere Vasseur, MD
• Organization: Onxeo

b.vasseur@onxeo.com

+33 (0)1 45 58 76 00

Study Officials

• Bérangère Vasseur, MD

  Valerio Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 28, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-10

Locations

CH (1); DE (5); US (19); FR (13); HU (4); ES (9)