Trial · NCT00803595
A Multinational Phase III Study of CS-8958 (MARVEL)
NCT00803595, Phase 3, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2011-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multinational Phase III Study of CS-8958 (MARVEL). Trials, record NCT00803595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00803595
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multinational Phase III Study of CS-8958 (MARVEL)
- NCT number
- NCT00803595
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,002 participants, actual
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Conditions
- Influenza, Human
- Interventions
- CS-8958, CS-8958, oseltamivir phosphate
- First posted
- 2008-12-05
- Last updated
- 2019-01-09
- Results first posted
- 2011-11-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Alleviation of Influenza Illness | 15 days | The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were "absent" or "mild." Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored. |
| Secondary | Time for Body Temperature to Return to Normal | 15 days | Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Alleviation of Influenza Illness | 15 days | Full analysis set (FAS) was defined as the set of subjects who had a positive test result using the influenza rapid diagnostic kit, received at least 1 dose of the study drug, and had valid efficacy data. | hours | MEDIAN |
| SECONDARY | Time for Body Temperature to Return to Normal | 15 days | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Alleviation of Influenza Illness | CS-8958 High Dose 40 mg | 73.0 | 95% Confidence Interval 68.4 to 80.8 | hours | |
| Time to Alleviation of Influenza Illness | CS-8958 Low Dose 20 mg | 85.8 | 95% Confidence Interval 76.5 to 92.8 | hours | |
| Time to Alleviation of Influenza Illness | Oseltamivir 75 mg | 73.6 | 95% Confidence Interval 68.5 to 83.3 | hours | |
| Time for Body Temperature to Return to Normal | CS-8958 High Dose 40 mg | 55.3 | 95% Confidence Interval 46.6 to 64.0 | hours | |
| Time for Body Temperature to Return to Normal | CS-8958 Low Dose 20 mg | 58.0 | 95% Confidence Interval 52.3 to 66.9 | hours | |
| Time for Body Temperature to Return to Normal | Oseltamivir 75 mg | 54.7 | 95% Confidence Interval 48.2 to 62.2 | hours |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CS-8958 High Dose 40 mg | 337 | |
| Overall Study | STARTED | CS-8958 Low Dose 20 mg | 327 | |
| Overall Study | STARTED | Oseltamivir 75 mg | 338 | |
| Overall Study | COMPLETED | CS-8958 High Dose 40 mg | 322 | |
| Overall Study | COMPLETED | CS-8958 Low Dose 20 mg | 319 | |
| Overall Study | COMPLETED | Oseltamivir 75 mg | 322 | |
| Overall Study | NOT COMPLETED | CS-8958 High Dose 40 mg | 15 | |
| Overall Study | NOT COMPLETED | CS-8958 Low Dose 20 mg | 8 | |
| Overall Study | NOT COMPLETED | Oseltamivir 75 mg | 16 |
Source ClinicalTrials.gov
Adverse events39
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 | Diarrhoea | Gastrointestinal disorders | CS-8958 High Dose 40 mg | 26 | 337 | |
| other | Diarrhoea | Gastrointestinal disorders | CS-8958 Low Dose 20 mg | 18 | 326 | |
| other | Diarrhoea | Gastrointestinal disorders | Oseltamivir 75 mg | 26 | 336 | |
| other | Nausea | Gastrointestinal disorders | CS-8958 High Dose 40 mg | 4 | 337 | |
| other | Nausea | Gastrointestinal disorders | CS-8958 Low Dose 20 mg | 7 | 326 | |
| other | Nausea | Gastrointestinal disorders | Oseltamivir 75 mg | 6 | 336 | |
| other | Vomiting | Gastrointestinal disorders | CS-8958 High Dose 40 mg | 1 | 337 | |
| other | Vomiting | Gastrointestinal disorders | CS-8958 Low Dose 20 mg | 1 | 326 | |
| other | Vomiting | Gastrointestinal disorders | Oseltamivir 75 mg | 8 | 336 | |
| other | Gastroenteritis | Infections and infestations | CS-8958 High Dose 40 mg | 4 | 337 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CS-8958 High Dose 40 mg | ||
| Total, all-cause mortality | CS-8958 Low Dose 20 mg | ||
| Total, all-cause mortality | Oseltamivir 75 mg | ||
| Total, other adverse events | CS-8958 High Dose 40 mg | 63 | 337 |
| Total, other adverse events | CS-8958 Low Dose 20 mg | 54 | 326 |
| Total, other adverse events | Oseltamivir 75 mg | 63 | 336 |
| Total, serious adverse events | CS-8958 High Dose 40 mg | 0 | 337 |
| Total, serious adverse events | CS-8958 Low Dose 20 mg | 0 | 326 |
| Total, serious adverse events | Oseltamivir 75 mg | 2 | 336 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20936975 | DERIVED |
Source PubMed
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/NCT00803595
GET https://conductscience.org/api/trials/v1/NCT00803595/events?page=2