Trial · NCT01385748
Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
NCT01385748, Phase 2, Completed, Valerio Therapeutics; results first posted 2017-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis. Trials, record NCT01385748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01385748
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis
- NCT number
- NCT01385748
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 183 participants, actual
- Lead sponsor
- Valerio Therapeutics
- Conditions
- Oral Mucositis
- Interventions
- Clonidine Lauriad® 50µg, Clonidine Lauriad® 100µg, Placebo Lauriad®
- First posted
- 2011-06-30
- Last updated
- 2017-11-28
- Results first posted
- 2017-08-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed | 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. |
| Secondary | At Least One Opioid Use (Class 3 Analgesic) | 8 weeks | Opioid use was recorded twice weekly during the active phase (radiotherapy) |
| Secondary | Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation) | 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. |
| Secondary | Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range) | 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. |
| Secondary | Overall Survival | 2 years | 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 . |
| Other | Time to Onset of Severe Oral Mucositis | 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. |
| Other | The Maximum Severity of Oral Mucositis | 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. |
| Other | The Overall Incidence of Grade 3/4 Mucositis During the Active Phase. | 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. |
| Other | Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher | 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). |
| Other | Overall Treatment Compliance According to the Patient Diary | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed | 8 weeks | The analysis was conducted on the Intent to treat population, defined as all participants who received at least one dose of investigational drug. | Cumulative radiation dose (Gy) | MEDIAN |
| SECONDARY | At Least One Opioid Use (Class 3 Analgesic) | 8 weeks | participants | NUMBER | |
| SECONDARY | Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation) | 8 weeks | Participants with at least one use of an opioid during the active phase with evaluable data. | morphine dose equivalent | MEAN |
| SECONDARY | Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range) | 8 weeks | Participants with at least one use of an opioid during the active phase with evaluable data. | morphine dose equivalent | MEDIAN |
| SECONDARY | Overall Survival | 2 years | The population for the 2-year OS follow-up was the ITT defined as all patients who received at least 1 dose of investigational drug. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Time to Onset of Severe Oral Mucositis | 8 weeks | weeks | MEDIAN | |
| OTHER_PRE_SPECIFIED | The Maximum Severity of Oral Mucositis | 8 weeks | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | The Overall Incidence of Grade 3/4 Mucositis During the Active Phase. | 8 weeks | Missing = participants without a WHO score during the active phase | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher | 8 weeks | Two of the 183 participants received study treatment but withdrew early without any safety assessments (1 in the clonidine Lauriad 50 μg group and 1 in the clonidine Lauriad 100 μg group). The safety population therefore included 181 participants. | weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Overall Treatment Compliance According to the Patient Diary | 8 weeks | Participants with evaluable data. | percentage of compliance | MEAN |
Source ClinicalTrials.gov
Results by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed | Clonidine Lauriad® 50 µg | 66 | 95% Confidence Interval 44 to NA | Cumulative radiation dose (Gy) | |
| Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed | Clonidine Lauriad® 100 µg | 56 | 95% Confidence Interval 44 to NA | Cumulative radiation dose (Gy) | |
| Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed | Placebo Lauriad® | 48 | 95% Confidence Interval 42 to 61.6 | Cumulative radiation dose (Gy) | |
| Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed | Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled | 60 | 95% Confidence Interval 48 to NA | Cumulative radiation dose (Gy) | |
| At Least One Opioid Use (Class 3 Analgesic) | Clonidine Lauriad® 50 µg | Missing | 2 | participants | |
| At Least One Opioid Use (Class 3 Analgesic) | Clonidine Lauriad® 100 µg | Missing | 1 | participants | |
| At Least One Opioid Use (Class 3 Analgesic) | Placebo Lauriad® | Missing | 0 | participants | |
| At Least One Opioid Use (Class 3 Analgesic) | Clonidine Lauriad® 50 µg | Yes | 23 | participants | |
| At Least One Opioid Use (Class 3 Analgesic) | Clonidine Lauriad® 100 µg | Yes | 30 | participants | |
| At Least One Opioid Use (Class 3 Analgesic) | Placebo Lauriad® | Yes | 30 | participants |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clonidine Lauriad® 50 µg | 56 | |
| Overall Study | STARTED | Clonidine Lauriad® 100 µg | 65 | |
| Overall Study | STARTED | Placebo Lauriad® | 62 | |
| Overall Study | COMPLETED | Clonidine Lauriad® 50 µg | 41 | |
| Overall Study | COMPLETED | Clonidine Lauriad® 100 µg | 51 | |
| Overall Study | COMPLETED | Placebo Lauriad® | 49 | |
| Overall Study | NOT COMPLETED | Clonidine Lauriad® 50 µg | 15 | |
| Overall Study | NOT COMPLETED | Clonidine Lauriad® 100 µg | 14 | |
| Overall Study | NOT COMPLETED | Placebo Lauriad® | 13 |
Source ClinicalTrials.gov
Adverse events364
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Clonidine Lauriad® 50µg | 9 | 55 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Clonidine Lauriad® 100µg | 12 | 64 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Lauriad® | 11 | 62 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled | 21 | 119 | 27 |
| other | Leukopenia | Blood and lymphatic system disorders | Clonidine Lauriad® 50µg | 10 | 55 | 17 |
| other | Leukopenia | Blood and lymphatic system disorders | Clonidine Lauriad® 100µg | 12 | 64 | 19 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Lauriad® | 8 | 62 | 11 |
| other | Leukopenia | Blood and lymphatic system disorders | Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled | 22 | 119 | 36 |
| other | Neutropenia | Blood and lymphatic system disorders | Clonidine Lauriad® 50µg | 7 | 55 | 9 |
| other | Neutropenia | Blood and lymphatic system disorders | Clonidine Lauriad® 100µg | 12 | 64 | 15 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clonidine Lauriad® 50µg | ||
| Total, all-cause mortality | Clonidine Lauriad® 100µg | ||
| Total, all-cause mortality | Placebo Lauriad® | ||
| Total, all-cause mortality | Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled | ||
| Total, other adverse events | Clonidine Lauriad® 50µg | 48 | 55 |
| Total, other adverse events | Clonidine Lauriad® 100µg | 60 | 64 |
| Total, other adverse events | Placebo Lauriad® | 61 | 62 |
| Total, other adverse events | Clonidine Lauriad® Muco-adhesive Buccal Tablets Pooled | 108 | 119 |
| Total, serious adverse events | Clonidine Lauriad® 50µg | 16 | 55 |
| Total, serious adverse events | Clonidine Lauriad® 100µg | 21 | 64 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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