Trial · NCT00109031
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
NCT00109031, Phase 3, Completed, Swedish Orphan Biovitrum; results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE). Trials, record NCT00109031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00109031
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
- NCT number
- NCT00109031
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 47 participants, actual
- Lead sponsor
- Swedish Orphan Biovitrum
- Conditions
- Cancer, Lymphoma, Leukemia
- Interventions
- palifermin, Total Body Irradiation, Cyclophosphamide, Etoposide, Placebo
- First posted
- 2005-04-25
- Last updated
- 2014-09-15
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Up to Day 28 | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. |
| Secondary | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | Up to Day 28 | The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study. |
| Secondary | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | From the first day of study drug administration through Day 28 | The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS. |
| Secondary | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Up to Day 28 | Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia. |
| Secondary | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Up to Day 28 | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. |
| Secondary | Duration of WHO Grade 2, 3 or 4 Oral Mucositis | Up to Day 28 | The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study. OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. |
| Secondary | Number of Participants With WHO Grade 4 Oral Mucositis | Up to Day 28 | Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Up to Day 28 | Primary analysis set | participants | NUMBER |
| SECONDARY | Duration of Severe Oral Mucositis (WHO Grade 3 and 4) | Up to Day 28 | Primary analysis set | days | MEAN |
| SECONDARY | Area Under the Curve (AUC) of Mouth and Throat Soreness Score | From the first day of study drug administration through Day 28 | Primary analysis set with available MTS data | MTS score * days | MEAN |
| SECONDARY | Number of Participants With Parenteral or Transdermal Opioid Analgesic Use | Up to Day 28 | Primary analysis set | participants | NUMBER |
| SECONDARY | Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis | Up to Day 28 | Primary analysis set | participants | NUMBER |
| SECONDARY | Duration of WHO Grade 2, 3 or 4 Oral Mucositis | Up to Day 28 | Primary analysis set with available OM assessment data | days | MEAN |
| SECONDARY | Number of Participants With WHO Grade 4 Oral Mucositis | Up to Day 28 | Primary analysis set | participants | NUMBER |
Source ClinicalTrials.gov
Results by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 60 µg/kg for 3 Days | Yes | 9 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -1 | Yes | 6 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -2 | Yes | 4 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -3 | Yes | 9 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 60 µg/kg for 3 Days | No | 2 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -1 | No | 3 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -2 | No | 9 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -3 | No | 3 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 60 µg/kg for 3 Days | Missing | 0 | participants | |
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4) | Palifermin 180 μg/kg on Day -1 | Missing | 1 | participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palifermin 60 µg/kg for 3 Days | 11 | |
| Overall Study | STARTED | Palifermin 180 μg/kg on Day -1 | 10 | |
| Overall Study | STARTED | Palifermin 180 μg/kg on Day -2 | 14 | |
| Overall Study | STARTED | Palifermin 180 μg/kg on Day -3 | 12 | |
| Overall Study | COMPLETED | Palifermin 60 µg/kg for 3 Days | 11 | |
| Overall Study | COMPLETED | Palifermin 180 μg/kg on Day -1 | 8 | |
| Overall Study | COMPLETED | Palifermin 180 μg/kg on Day -2 | 12 | |
| Overall Study | COMPLETED | Palifermin 180 μg/kg on Day -3 | 12 | |
| Overall Study | NOT COMPLETED | Palifermin 60 µg/kg for 3 Days | 0 | |
| Overall Study | NOT COMPLETED | Palifermin 180 μg/kg on Day -1 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events836
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 | Palifermin 60 µg/kg for 3 Days (A) | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Palifermin 180 μg/kg on Day -1 (B) | 1 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Palifermin 180 μg/kg on Day -2 (C) | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Palifermin 180 μg/kg on Day -3 (D) | 0 | 12 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Palifermin 60 µg/kg for 3 Days (A) | 2 | 10 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Palifermin 180 μg/kg on Day -1 (B) | 0 | 11 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Palifermin 180 μg/kg on Day -2 (C) | 1 | 13 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Palifermin 180 μg/kg on Day -3 (D) | 1 | 12 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Palifermin 60 µg/kg for 3 Days (A) | 0 | 10 | |
| other | Arrhythmia supraventricular | Cardiac disorders | Palifermin 180 μg/kg on Day -1 (B) | 0 | 11 |
1 to 10 of 836Source ClinicalTrials.gov
See all 836 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palifermin 60 µg/kg for 3 Days (A) | ||
| Total, all-cause mortality | Palifermin 180 μg/kg on Day -1 (B) | ||
| Total, all-cause mortality | Palifermin 180 μg/kg on Day -2 (C) | ||
| Total, all-cause mortality | Palifermin 180 μg/kg on Day -3 (D) | ||
| Total, other adverse events | Palifermin 60 µg/kg for 3 Days (A) | 9 | 10 |
| Total, other adverse events | Palifermin 180 μg/kg on Day -1 (B) | 10 | 11 |
| Total, other adverse events | Palifermin 180 μg/kg on Day -2 (C) | 12 | 13 |
| Total, other adverse events | Palifermin 180 μg/kg on Day -3 (D) | 12 | 12 |
| Total, serious adverse events | Palifermin 60 µg/kg for 3 Days (A) | 1 | 10 |
| Total, serious adverse events | Palifermin 180 μg/kg on Day -1 (B) | 3 | 11 |
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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