Influenza, HumanPhase 3MARVELNCT00803595

A Multinational Phase III Study of CS-8958 (MARVEL)

A Phase 3 study testing CS-8958 and oseltamivir phosphate in people with Influenza, Human, run by Daiichi Sankyo Co., Ltd. at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Influenza, Human
What is being tested?: CS-8958 and oseltamivir phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,002 participants
Where: 4 sitesin 4 countries
Study dates: Nov 2008to Jun 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Who cannot join

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

China1 site

Study site
Hong Kong

Other trials in China

Japan1 site

Study site
Tokyo

Other trials in Japan

South Korea1 site

Study site
Seoul

Other trials in South Korea

Taiwan1 site

Study site
Taipei

Other trials in Taiwan

About this study

Official title: A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection

In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.

Conditions: Influenza, Human
Being tested: CS-8958, oseltamivir phosphate
Keywords: Influenza, Neuraminidase inhibitor
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS-8958Drug
CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
CS-8958Drug
CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
oseltamivir phosphateDrug
CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.

Study groups in NCT00803595
Study group	Role	What they receive
CS-8958 Low Dose	Experimental	CS-8958 powder to be inhaled - low-dose arm Receives: Drug: CS-8958
CS-8958 High Dose	Experimental	CS-8958 powder to be inhaled - high-dose arm Receives: Drug: CS-8958
Oseltamivir phosphate	Active comparator	oseltamivir phosphate oral capsules Receives: Drug: oseltamivir phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Alleviation of Influenza Illness
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.
Measured: 15 days

Secondary outcomes (1)

Time for Body Temperature to Return to Normal
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.
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Jun 2009

First posted5 Dec 2008 (estimated)
Study startNov 2008
Primary completionMar 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,002 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00803595
Sponsor's protocol ID: CS8958-A-J301
Acronym: MARVEL
Status last verified: Nov 2011
First submitted: 4 Dec 2008
Last updated: 9 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

Watanabe A, Chang SC, Kim MJ, Chu DW, Ohashi Y; MARVEL Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010 Nov 15;51(10):1167-75. doi: 10.1086/656802. Epub 2010 Oct 11.
PubMed 20936975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection
ClinicalTrials.gov ID: NCT00803595
Acronym / sponsor ID: MARVEL / CS8958-A-J301
Conditions: Influenza, Human
Keywords: Influenza, Neuraminidase inhibitor
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,002 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Mar 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 5 Dec 2008 (estimated)
Results: Posted 22 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
CS-8958 Low Dose	Experimental	Drug: CS-8958CS-8958 powder to be inhaled - low-dose arm
CS-8958 High Dose	Experimental	Drug: CS-8958CS-8958 powder to be inhaled - high-dose arm
Oseltamivir phosphate	Active comparator	Drug: oseltamivir phosphateoseltamivir phosphate oral capsules

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Clinical diagnosis of influenza
Axillary temperature of > or = to 37.5 degrees C

Key exclusion criteria (3 listed)

Infection by bacteria species and/or virus other than influenza virus
Chronic respiratory disease
Renal dysfunction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CS-8958CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days	Drug	CS-8958 Low Dose
CS-8958CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days	Drug	CS-8958 High Dose
oseltamivir phosphateCS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.	Drug	Oseltamivir phosphate

Primary outcome

Time to Alleviation of Influenza Illness
Time frame: 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.

1 secondary outcome

Time for Body Temperature to Return to Normal
Time frame: 15 days

Results and safety

Results posted to the registry on 22 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CS-8958 High Dose 40 mg	337	322
CS-8958 Low Dose 20 mg	327	319
Oseltamivir 75 mg	338	322

Primary outcome: Time to Alleviation of Influenza Illness

Time frame: 15 days. Median (95% Confidence Interval). Unit: hours

Measure	CS-8958 High Dose 40 mg n = 334	CS-8958 Low Dose 20 mg n = 326	Oseltamivir 75 mg n = 336
Value	73.0 (68.4 to 80.8)	85.8 (76.5 to 92.8)	73.6 (68.5 to 83.3)

CS-8958 Low Dose 20 mg vs Oseltamivir 75 mg: Median Difference (Final Values): -0.6 (95% CI -9.9 to 6.9), p = 0.748, Generalized Wilcoxon Test
CS-8958 High Dose 40 mg vs CS-8958 Low Dose 20 mg: Median Difference (Final Values): -12.8 (95% CI -18.2 to -0.4), p = 0.038, Generalized Wilcoxon Test
CS-8958 Low Dose 20 mg vs Oseltamivir 75 mg: Median Difference (Final Values): 12.2 (95% CI -1.5 to 17.2), p = 0.104, Generalized Wilcoxon test

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 15 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CS-8958 High Dose 40 mg	0 of 337 (0%)	63 of 337 (18.7%)	Not reported
CS-8958 Low Dose 20 mg	0 of 326 (0%)	54 of 326 (16.6%)	Not reported
Oseltamivir 75 mg	2 of 336 (0.6%)	63 of 336 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20936975Watanabe A, Chang SC, Kim MJ, Chu DW, Ohashi Y; MARVEL Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010 Nov 15;51(10):1167-75. doi: 10.1086/656802. Epub 2010 Oct 11.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Influenza, Human

Active, not recruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CS-8958 and oseltamivir phosphate in people with Influenza, Human, run by Daiichi Sankyo Co., Ltd. at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China, Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Alleviation of Influenza Illness (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00803595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.