Trial · NCT02229539
Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
NCT02229539, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-04-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy. Trials, record NCT02229539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02229539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
- NCT number
- NCT02229539
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 275 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Acute Oral Mucositis Pain
- Interventions
- doxepin hydrochloride oral solution, DLA (diphenhydramine, lidocaine and antacids) rinse, Placebo
- First posted
- 2014-09-01
- Last updated
- 2025-05-18
- Results first posted
- 2017-04-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Area Under the Curve (AUC) of Total Pain Reduction | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment | Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. |
| Secondary | Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | 5, 15, 30, 60, 120, 240 minutes post treatment | Total unpleasant taste was measured by the numerical analogue scale of taste of the oral rinse on a scale of 0 to 10, with 0=acceptable and 10=terrible in the questionnaires taken at 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total unpleasant taste was calculated by the area under the curve (AUC) adjusting for 5 minutes post treatment, with time scale (5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 1, 2, 3, 4 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing 5 minutes after treatment data, or only provided 5 minutes after treatment data, he/she was excluded from the statistical analysis. |
| Secondary | Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | 5, 15, 30, 60, 120, 240 minutes post treatment | Total stinging or burning was measured by the numerical analogue scale of stinging or burning from the oral rinse on a scale of 0 to 10, with 0=no stinging or burning and 10=worst stinging or burning possible in the questionnaires taken at 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total stinging or burning was calculated by the area under the curve (AUC) adjusting for 5 minutes post treatment, with time scale (5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 1, 2, 3, 4 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing 5 minutes after treatment data, or only provided 5 minutes after treatment data, he/she was excluded from the statistical analysis. |
| Secondary | Area Under the Curve (AUC) of Total Drowsiness | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment | Total drowsiness was measured by the numerical analogue scale of drowsiness on a scale of 0 to 10, with 0=no drowsiness and 10=extreme drowsiness, leading to sleep in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total drowsiness was calculated by the area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis. |
| Secondary | The Incidence of Using Alternative Analgesics | At 120 and 240 minutes post treatment | Patients were asked if they have taken any other pain medications, if yes, to record the name, strength and when they have taken the pain medications in the 120 minutes and 240 minutes post treatment questionnaires. |
| Secondary | Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase | At 240 minutes post treatment | Patients were asked: "Based on your experience with this current oral rinsing medication, would you want to take another dose now if it were available?" in the 240 minutes post treatment questionnaire. |
| Secondary | Frequency of Study Rinse Used in the Continuation Phase | Up to 7 days. | Patients were asked: "Did you use the study rinse today?" daily questionnaire during the optional continuation phase (Cycle 2). |
| Secondary | Median Mouth Pain Score in the Continuation Phase | Day 1 to Day 7 in the Continuation Phase | Mouth pain scores was measured using the numerical analogue scale ranging from scale of 0 to 10, with 0=no pain and 10=worst pain daily during the optional continuation phase (Cycle 2). |
| Secondary | The Incidence of Using Alternative Analgesics in the Continuation Phase | Day 1 to Day 7 in the Continuation Phase | Patients were asked if they have taken any medications for pain over the past 24 hours, if yes, to record the name, strength and when they have taken the pain medications daily during the optional continuation phase (Cycle 2). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Area Under the Curve (AUC) of Total Pain Reduction | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and had mouth and throat pain data at baseline and at least one time point beyond baseline. | units on a scale*time scale | MEAN |
| SECONDARY | Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | 5, 15, 30, 60, 120, 240 minutes post treatment | units on a scale*units on a scale | MEDIAN | |
| SECONDARY | Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | 5, 15, 30, 60, 120, 240 minutes post treatment | units on a scale*units on a scale | MEDIAN | |
| SECONDARY | Area Under the Curve (AUC) of Total Drowsiness | Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment | units on a scale*units on a scale | MEDIAN | |
| SECONDARY | The Incidence of Using Alternative Analgesics | At 120 and 240 minutes post treatment | Some patients are missing their Additional Analgesic Use. All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and has responded to the question about if they have taken any other pain medications at the indicated time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase | At 240 minutes post treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency of Study Rinse Used in the Continuation Phase | Up to 7 days. | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain, completed the cycle 1 treatment, has started treatment in the optional continuation phase and has responded to the question. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Mouth Pain Score in the Continuation Phase | Day 1 to Day 7 in the Continuation Phase | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain, completed the cycle 1 treatment, has started treatment in the optional continuation phase and has responded to the question. | units on a scale | MEDIAN |
| SECONDARY | The Incidence of Using Alternative Analgesics in the Continuation Phase | Day 1 to Day 7 in the Continuation Phase | All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and has responded to the question about if they have taken any other pain medications at the indicated time point. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Area Under the Curve (AUC) of Total Pain Reduction | Doxepin | 11.6 | Standard Deviation 9.7 | units on a scale*time scale | |
| Mean Area Under the Curve (AUC) of Total Pain Reduction | DLA (Diphenhydramine, Lidocaine and Antacid) | 11.7 | Standard Deviation 8.1 | units on a scale*time scale | |
| Mean Area Under the Curve (AUC) of Total Pain Reduction | Placebo | 8.7 | Standard Deviation 9.9 | units on a scale*time scale | |
| Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | Doxepin | 3.5 | Inter-Quartile Range 0 to 8.5 | units on a scale*units on a scale | |
| Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | DLA (Diphenhydramine, Lidocaine and Antacid) | 2.0 | Inter-Quartile Range 0 to 6.3 | units on a scale*units on a scale | |
| Area Under the Curve (AUC) of Total Unpleasant Taste of the Oral Rinse | Placebo | 0.8 | Inter-Quartile Range 0 to 3.0 | units on a scale*units on a scale | |
| Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | Doxepin | 5.3 | Inter-Quartile Range 2.5 to 11.0 | units on a scale*units on a scale | |
| Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | DLA (Diphenhydramine, Lidocaine and Antacid) | 0.8 | Inter-Quartile Range 0 to 4.8 | units on a scale*units on a scale | |
| Area Under the Curve (AUC) of Total Stinging or Burning From the Oral Rinse | Placebo | 0.5 | Inter-Quartile Range 0 to 3.0 | units on a scale*units on a scale | |
| Area Under the Curve (AUC) of Total Drowsiness | Doxepin | 0 | Inter-Quartile Range -2.5 to 3.0 | units on a scale*units on a scale |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cycle 1 (Treatment Per Protocol) | STARTED | Doxepin | 78 | |
| Cycle 1 (Treatment Per Protocol) | STARTED | DLA (Diphenhydramine, Lidocaine and Antacid) | 76 | |
| Cycle 1 (Treatment Per Protocol) | STARTED | Placebo | 76 | |
| Cycle 1 (Treatment Per Protocol) | COMPLETED | Doxepin | 78 | |
| Cycle 1 (Treatment Per Protocol) | COMPLETED | DLA (Diphenhydramine, Lidocaine and Antacid) | 75 | |
| Cycle 1 (Treatment Per Protocol) | COMPLETED | Placebo | 74 | |
| Cycle 1 (Treatment Per Protocol) | NOT COMPLETED | Doxepin | 0 | |
| Cycle 1 (Treatment Per Protocol) | NOT COMPLETED | DLA (Diphenhydramine, Lidocaine and Antacid) | 1 | |
| Cycle 1 (Treatment Per Protocol) | NOT COMPLETED | Placebo | 2 | |
| Cycle 2 (Optional Continuation Phase) | STARTED | Doxepin | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events135
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 | Constipation | Gastrointestinal disorders | Doxepin | 1 | 78 | 1 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 72 | 1 |
| other | Constipation | Gastrointestinal disorders | DLA (Diphenhydramine, Lidocaine and Antacid) | 1 | 74 | 2 |
| other | Dry mouth | Gastrointestinal disorders | Doxepin | 4 | 78 | 4 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 1 | 72 | 2 |
| other | Dry mouth | Gastrointestinal disorders | DLA (Diphenhydramine, Lidocaine and Antacid) | 0 | 74 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Doxepin | 0 | 78 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 72 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | DLA (Diphenhydramine, Lidocaine and Antacid) | 1 | 74 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Doxepin | 0 | 78 | 0 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxepin | 0 | 78 |
| Total, all-cause mortality | Placebo | 0 | 76 |
| Total, all-cause mortality | DLA (Diphenhydramine, Lidocaine and Antacid) | 0 | 76 |
| Total, other adverse events | Doxepin | 17 | 78 |
| Total, other adverse events | Placebo | 7 | 72 |
| Total, other adverse events | DLA (Diphenhydramine, Lidocaine and Antacid) | 8 | 74 |
| Total, serious adverse events | Doxepin | 2 | 78 |
| Total, serious adverse events | Placebo | 3 | 72 |
| Total, serious adverse events | DLA (Diphenhydramine, Lidocaine and Antacid) | 3 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30990550 | DERIVED |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UG1CA189823 | Alliance NCORP Research Base | PASKETT, ELECTRA D.; GALANIS, EVANTHIA; HAHN, OLWEN | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| U10CA037447 | Cancer and Leukemia Group B CCOP Research Base | BERTAGNOLLI, MONICA M; PASKETT, ELECTRA D. | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2015 | NIH RePORTER |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02229539
GET https://conductscience.org/api/trials/v1/NCT02229539/results?page=2