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

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• Mucositis 488
• Stomatitis 401

Mucositis

488 studies on the registry are indexed under Mucositis; 70 are open to participants now.

This study's enrollment of 183 is above the median of 50 across 394 interventional studies indexed under Mucositis.

Lead sponsor

Valerio Therapeutics is the lead sponsor of 25 studies on the registry; none are open to participants now.

Study arms

• Active comparator
  Clonidine Lauriad® 50µg

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

  Drug: Clonidine Lauriad® 50µg

• Active comparator
  Clonidine Lauriad® 100µg

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

  Drug: Clonidine Lauriad® 100µg

• Placebo comparator
  Placebo Lauriad®

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

  Drug: Placebo Lauriad®

Interventions

• DrugClonidine Lauriad® 50µg

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

• DrugClonidine Lauriad® 100µg

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

• DrugPlacebo Lauriad®

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

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.

   Time frame: 8 weeks

Secondary outcomes

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

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

   Time frame: 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.

   Time frame: 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.

   Time frame: 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 .

   Time frame: 2 years

Other outcomes

1. Time to Onset of Severe Oral Mucositis

   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

2. The Maximum Severity of Oral Mucositis

   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

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

   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

4. Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher

   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

5. Overall Treatment Compliance According to the Patient Diary

   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

Baseline characteristics

9 further baseline measures are reported on the registry.