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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385748
First Posted: June 30, 2011
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Onxeo
June 29, 2011
June 30, 2011
October 27, 2016
August 9, 2017
August 9, 2017
April 2010
October 2014   (Final data collection date for primary outcome measure)
Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed [ Time Frame: 8 weeks ]
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.
Percentage of patients with an oral mucositis score≥ 3 using the WHO scale at cumulative radiation dose of 50 Gy [ Time Frame: 8 weeks ]
Comparison between groups of the percentage of patients with an oral mucositis score ≥ 3 using the WHO scale at cumulative radiation dose of 50 Gy.
Complete list of historical versions of study NCT01385748 on ClinicalTrials.gov Archive Site
  • At Least One Opioid Use (Class 3 Analgesic) [ Time Frame: 8 weeks ]
    Opioid use was recorded twice weekly during the active phase (radiotherapy)
  • Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation) [ Time Frame: 8 weeks ]
    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) [ Time Frame: 8 weeks ]
    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.
Percentage of patients with an oral mucositis score≥ 3 using the WHO scale at cumulative radiation doses of 40 Gy and 60 Gy [ Time Frame: 8 weeks ]
  • Time to Onset of Severe Oral Mucositis [ Time Frame: 8 weeks ]
    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.
  • The Maximum Severity of Oral Mucositis [ Time Frame: 8 weeks ]
    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.
  • The Overall Incidence of Grade 3/4 Mucositis During the Active Phase. [ Time Frame: 8 weeks ]
    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.
  • Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher [ Time Frame: 8 weeks ]
    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).
  • Overall Treatment Compliance According to the Patient Diary [ Time Frame: 8 weeks ]
    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.
Not Provided
 
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Oral Mucositis
  • Drug: Clonidine Lauriad® 50µg
    50µg muco-adhesive buccal tablet once day every day up to 8 weeks
  • Drug: Clonidine Lauriad® 100µg
    100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
  • Drug: Placebo Lauriad®
    placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
  • Active Comparator: Clonidine Lauriad® 50µg
    50µg muco-adhesive buccal tablets, once de day, every day up to 8 weeks
    Intervention: Drug: Clonidine Lauriad® 50µg
  • Active Comparator: Clonidine Lauriad® 100µg
    100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
    Intervention: Drug: Clonidine Lauriad® 100µg
  • Placebo Comparator: Placebo Lauriad®
    Placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
    Intervention: Drug: Placebo Lauriad®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
December 2014
October 2014   (Final data collection date for primary outcome measure)

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:

    1. 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.
    2. 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:

    1. Haemoglobin ≥ 10g/dL
    2. Absolute neutrophil counts ≥ 1500 cells/mm3
    3. Platelets ≥ 100.000/mm3
    4. Conjugated bilirubin ≤ 2 times Upper Limit of Normal (ULN)
    5. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 ULN
    6. 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Hungary,   Spain,   Switzerland,   United States
 
 
NCT01385748
BA2009/28/01
No
Not Provided
Not Provided
Onxeo
Onxeo
Not Provided
Study Director: Bérangère Vasseur, MD Onxeo
Onxeo
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP