Trial · NCT00718315
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
NCT00718315, Phase 3, Completed, Hoffmann-La Roche; results first posted 2015-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash. Trials, record NCT00718315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00718315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
- NCT number
- NCT00718315
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 201 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- erlotinib [Tarceva], fusidic acid [Verutex], erythromycin [Eritex], Fisiogel
- First posted
- 2008-07-18
- Last updated
- 2015-01-15
- Results first posted
- 2015-01-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Develop Skin Rash | 30 Days | Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash"). |
| Primary | Percentage of Participants With Skin Rash Stratified by Severity Grade | 30 Days | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death |
| Secondary | Time to Appearance of Skin Rash | Days 0, 15, and 30 | Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE |
| Secondary | Percentage of Participants With Erythema | Days 0, 15, and 30 | Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries |
| Secondary | Percentage of Participants With Pruritus | Days 0, 15, and 30 | Pruritus is defined as intense localized itching |
| Secondary | Percentage of Participants With Pain | Days 0, 15, and 30 | Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli |
| Secondary | Percentage of Participants With Erythema Stratified by Severity Grade | 30 Days | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. |
| Secondary | Percentage of Participants With Pruritus Stratified by Severity Grade | 30 Days | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. |
| Secondary | Percentage of Participants With Pain Stratified by Severity Grade | 30 Days | The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. |
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 | Percentage of Participants Who Develop Skin Rash | 30 Days | ITT Population | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Skin Rash Stratified by Severity Grade | 30 Days | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Time to Appearance of Skin Rash | Days 0, 15, and 30 | ITT Population | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Erythema | Days 0, 15, and 30 | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pruritus | Days 0, 15, and 30 | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain | Days 0, 15, and 30 | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Erythema Stratified by Severity Grade | 30 Days | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pruritus Stratified by Severity Grade | 30 Days | ITT Population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pain Stratified by Severity Grade | 30 Days | ITT Population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Develop Skin Rash | Fisiogel | 60.0 | 95% Confidence Interval 47.1 to 72.0 | percentage of participants | |
| Percentage of Participants Who Develop Skin Rash | Stiemicyn | 69.2 | 95% Confidence Interval 56.6 to 80.1 | percentage of participants | |
| Percentage of Participants Who Develop Skin Rash | Verutex | 73.1 | 95% Confidence Interval 60.9 to 83.2 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Fisiogel | Grade 0 | 29.8 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Stiemicyn | Grade 0 | 25.0 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Verutex | Grade 0 | 18.3 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Fisiogel | Grade 1 | 21.1 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Stiemicyn | Grade 1 | 18.3 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Verutex | Grade 1 | 43.3 | percentage of participants | |
| Percentage of Participants With Skin Rash Stratified by Severity Grade | Fisiogel | Grade 2 | 49.1 | percentage of participants |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fisiogel | 67 | |
| Overall Study | STARTED | Stiemicyn | 67 | |
| Overall Study | STARTED | Verutex | 67 | |
| Overall Study | COMPLETED | Fisiogel | 48 | |
| Overall Study | COMPLETED | Stiemicyn | 45 | |
| Overall Study | COMPLETED | Verutex | 46 | |
| Overall Study | NOT COMPLETED | Fisiogel | 19 | |
| Overall Study | NOT COMPLETED | Stiemicyn | 22 | |
| Overall Study | NOT COMPLETED | Verutex | 21 |
Source ClinicalTrials.gov
Adverse events183
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 | Diarrhea | Gastrointestinal disorders | Fisiogel | 15 | 67 | |
| other | Diarrhea | Gastrointestinal disorders | Stiemicyn | 18 | 66 | |
| other | Diarrhea | Gastrointestinal disorders | Verutex | 14 | 67 | |
| other | Anorexia | Gastrointestinal disorders | Fisiogel | 5 | 67 | |
| other | Anorexia | Gastrointestinal disorders | Stiemicyn | 7 | 66 | |
| other | Anorexia | Gastrointestinal disorders | Verutex | 6 | 67 | |
| other | Nausea | Gastrointestinal disorders | Fisiogel | 3 | 67 | |
| other | Nausea | Gastrointestinal disorders | Stiemicyn | 4 | 66 | |
| other | Nausea | Gastrointestinal disorders | Verutex | 3 | 67 | |
| other | Mucositis/stomatitis (clinical exam) - oral cavity | Gastrointestinal disorders | Fisiogel | 2 | 67 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fisiogel | ||
| Total, all-cause mortality | Stiemicyn | ||
| Total, all-cause mortality | Verutex | ||
| Total, other adverse events | Fisiogel | 45 | 67 |
| Total, other adverse events | Stiemicyn | 45 | 66 |
| Total, other adverse events | Verutex | 48 | 67 |
| Total, serious adverse events | Fisiogel | 12 | 67 |
| Total, serious adverse events | Stiemicyn | 13 | 66 |
| Total, serious adverse events | Verutex | 19 | 67 |
Source ClinicalTrials.gov
Papers0
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.
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/NCT00718315
GET https://conductscience.org/api/trials/v1/NCT00718315/results?page=2