Back to resultsEfficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
Primary Purpose
Oral Mucositis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Clonidine Lauriad® 50µg
Clonidine Lauriad® 100µg
Placebo Lauriad®
Sponsored by
About this trial
This is an interventional treatment trial for Oral Mucositis
Eligibility Criteria
Inclusion Criteria:
- 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
- Women of child bearing potential must have effective contraception method (oral or device)
- Signed written informed consent
Exclusion Criteria:
- 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
- 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
Sites / Locations
- 21st Century Oncology of Arizona
- Compassionate Cancer Care Medical Group
- City of Hope
- California Cancer Associates for Researche and Excellence
- Compassionate Cancer Care Medical Group
- Central Coast Medical Oncology Corp.
- Centura Health Research Center
- University of Connectcut Health Center
- AMPM Research Clinic
- Barbara Ann Karmonos Cancer Hospital
- Washington University School of medecine
- Billings Clinic Montana
- Winthrop University Hospital
- Montefiore Medical Center
- Carolinas Medical Center- Carolinas Health Care System
- University of Oklahoma Health Sciences Center
- Penn State Hershey Cancer Institut
- Vanderbilt Ingram Cancer Center
- Medical College of Wisconsin
- Hospital Jean Minjoz
- CHU Morvan
- Centre François Baclesse
- Clinique Pasteur
- Centre Oscar Lambret
- Clinique Chénieux
- Clinique Hartmann
- CH Lyon Sud
- CHU La Milétrie
- CHP St gregoire
- Centre de Cancérologie Etienne-Dolet
- Hôpital Bretonneau
- Institut Gustave Roussy
- Universitatsklinikum Erlangen Strahlenklinik
- Universitatsklinikum Essen
- Universitatsklinikum Freiburg Klinik fur Strahlentherapie
- Universitatsklinikum Leipzig
- Paracelsius- Klinik
- Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
- Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
- Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
- Szent Imre Kórház
- Hospital Vall d'Hebron
- Hospital Universitario de La princesa
- Hospital Clinico San Carlos
- Hospital 12 de octubre
- Hospital Puerta de Hierro Majadahonda
- Hospital Universitario Ramon y cajal
- Hospital Carlos Haya
- Hospital Virgen de la Victoria
- Hospital de Navarra
- Centre Hospitalier Universitaire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Clonidine Lauriad® 50µg
Clonidine Lauriad® 100µg
Placebo Lauriad®
Arm Description
50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
At Least One Opioid Use (Class 3 Analgesic)
Opioid use was recorded twice weekly during the active phase (radiotherapy)
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.
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.
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01385748
Brief Title
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onxeo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clonidine Lauriad® 50µg
Arm Type
Active Comparator
Arm Description
50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
Arm Title
Clonidine Lauriad® 100µg
Arm Type
Active Comparator
Arm Description
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Arm Title
Placebo Lauriad®
Arm Type
Placebo Comparator
Arm Description
Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Clonidine Lauriad® 50µg
Intervention Description
50µg muco-adhesive buccal tablet once day every day up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Clonidine Lauriad® 100µg
Intervention Description
100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo Lauriad®
Intervention Description
placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
Primary Outcome Measure Information:
Title
Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
At Least One Opioid Use (Class 3 Analgesic)
Description
Opioid use was recorded twice weekly during the active phase (radiotherapy)
Time Frame
8 weeks
Title
Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)
Description
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.
Time Frame
8 weeks
Title
Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)
Description
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.
Time Frame
8 weeks
Title
Overall Survival
Description
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 .
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Time to Onset of Severe Oral Mucositis
Description
Time to onset is the duration until first Severe Oral Mucositis. Severe Oral Mucositis was defined as a Grade 3 or Grade 4 score on the World Health Organization (WHO) oral mucositis severity scale. Participants were 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 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.
Time Frame
8 weeks
Title
The Maximum Severity of Oral Mucositis
Description
Participants were assessed using the World Health Organization (WHO) oral mucositis severity scale 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. The WHO scores were as follows: 0 = None; 1 = oral soreness, erythema; 2 = oral erythema, ulcers, solid diet tolerated; 3 = oral ulcers, liquid diet only; 4 = oral alimentation impossible. The maximum severity was the maximum score reported during the active phase.
Time Frame
8 weeks
Title
The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.
Description
The presence of grade 3 or 4 oral mucositis on the World Health Organization (WHO) oral mucositis severity scale 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 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.The number of participants with at least one Grade 3 or Grade 4 mucositis score during the active phase is reported.
Time Frame
8 weeks
Title
Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher
Description
Salivary flow was assessed and scored by the investigator weekly using the NCI-CTC scale for xerostomia for up to 8 weeks during the active phase (radiotherapy). Time to appearance of Grade 2 or higher on the following 4-point scoring scale is reported: 0 = normal; 1 = symptomatic (dry or thick saliva) without significant dietary alteration (unstimulated saliva flow greater than 0.2 mL/minute); 2 = symptomatic and significant oral intake alterations (e.g. copious water, other lubricants, diet limited to purees and/or soft, moist foods) (unstimulated saliva 0.1 to 0.2 mL/minute); and 3 = symptoms leading to inability to adequately aliment orally, intravenous fluids, tube feedings, or total parenteral nutrition indicated (unstimulated saliva < 0.1 mL/minute).
Time Frame
8 weeks
Title
Overall Treatment Compliance According to the Patient Diary
Description
All participants complete a daily questionnaire during the active phase (radiotherapy). Compliance = [ number of tablets / (end date of treatment - start date treatment + 1 ) ] * 100. The "number of tablets" is the number of days with a tablet applied and treatment start and end dates are the first and last dates of the patient diary with a tablet applied.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Women of child bearing potential must have effective contraception method (oral or device)
Signed written informed consent
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bérangère Vasseur, MD
Organizational Affiliation
Onxeo
Official's Role
Study Director
Facility Information:
Facility Name
21st Century Oncology of Arizona
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
California Cancer Associates for Researche and Excellence
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Central Coast Medical Oncology Corp.
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Centura Health Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
University of Connectcut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
AMPM Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Barbara Ann Karmonos Cancer Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of medecine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic Montana
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Montefiore Medical Center
City
The Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Carolinas Medical Center- Carolinas Health Care System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Penn State Hershey Cancer Institut
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Morvan
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Clinique Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Clinique Chénieux
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Clinique Hartmann
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Facility Name
CH Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU La Milétrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHP St gregoire
City
Saint gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
Centre de Cancérologie Etienne-Dolet
City
Saint-Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitatsklinikum Erlangen Strahlenklinik
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitatsklinikum Freiburg Klinik fur Strahlentherapie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Paracelsius- Klinik
City
Osnabruck
ZIP/Postal Code
49076
Country
Germany
Facility Name
Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
City
Kecskemét
State/Province
Nyíri u. 38
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
City
Nyíregyháza
State/Province
Szent István út 68
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc,
State/Province
Szentpéteri kapu 72-76
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szent Imre Kórház
City
Budapest
State/Province
Tétényi út 12-16.
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de La princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital 12 de octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Ramon y cajal
City
Madrid
Country
Spain
Facility Name
Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Centre Hospitalier Universitaire
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
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