Clostridium DifficilePhase 3NCT02179658
A Study to Compare Safety and Efficacy of OPT-80(Fidaxomicin) With Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
A Phase 3 study testing OPT-80 and vancomycin in people with Clostridium Difficile, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- OPT-80 and vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 7 sitesJapan
- Study dates
- 23 Jun 2014to 8 Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Inpatients who have symptoms of CDAD as defined by;
- (1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and
- (2)Presence of either toxin A and/or B of C. difficile in the stool
- Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study
Who cannot join
- Life-threatening or fulminant CDAD
- Ileus paralytic or toxic megacolon
- Likelihood of death before the completion of study from any cause
- Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD
- The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent
- Subjects who in the opinion of the investigator require other drugs to control diarrhea
Show all 14Show fewer
- Need of change in dosage regimen of opiates during the study period
- Need of change in dosage regimen of probiotic products during the study period
- History/complications of ulcerative colitis or Crohn's disease
- Multiple occurrences of CDAD within the past three months
- Hypersensitivity to vancomycin
- Previous exposure to OPT-80 (fidaxomicin)
- Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study
- Participation in other clinical research studies or Post Marketing Clinical Trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kanto
Study site
Kinnki
Study site
Kyushu
Study site
Tōhoku
About this study
Official title: OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
Read the detailed description
This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.
- Conditions
- Clostridium Difficile
- Being tested
- OPT-80, vancomycin
- Keywords
- Clostridium, Infections, Difficile, Vancomycin, Fidaxomicin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPT-80Drug
Also called fidaxomicin
oral
vancomycinDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| OPT-80 group | Experimental | Oral Receives: Drug: OPT-80 |
| Vancomycin group | Active comparator | Oral Receives: Drug: vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cure rate
Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period
Measured: Up to 38 days
Secondary outcomes (9)
Cure rate
Measured: Day 10 -11 of the study period
Recurrence rate of CDAD
Measured: during the 4-week follow-up period, up to Day 38
Time to resolution of diarrhea
Measured: up to 38 days
Microbiological efficacy
Measured: Up to 38 days
Plasma concentration of OPT-80(fidaxomicin)
Measured: Before administration, Day 1 and Day 10-11
Plasma concentration of OP-1118
Measured: Before administration, Day 1 and Day 10-11
Fecal concentration of OPT-80(fidaxomicin)
Measured: Day 10-11
Fecal concentration of OP-1118
Measured: Day 10-11
Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests
Measured: Up to 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study start23 Jun 2014
- Primary completion8 Sep 2016
- Study completion8 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179658
- Sponsor's protocol ID
- 2819-CL-3002
- Status last verified
- Oct 2024
- First submitted
- 30 Jun 2014
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Mikamo H, Tateda K, Yanagihara K, Kusachi S, Takesue Y, Miki T, Oizumi Y, Gamo K, Hashimoto A, Toyoshima J, Kato K. Efficacy and safety of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in a randomized, double-blind, comparative Phase III study in Japan. J Infect Chemother. 2018 Sep;24(9):744-752. doi: 10.1016/j.jiac.2018.05.010. Epub 2018 Jun 19.
PubMed 29934056
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
- ClinicalTrials.gov ID
- NCT02179658
- Acronym / sponsor ID
- 2819-CL-3002
- Conditions
- Clostridium Difficile
- Keywords
- Clostridium, Infections, Difficile, Vancomycin, Fidaxomicin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
Detailed description
This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPT-80 group | Experimental | Drug: OPT-80Oral |
| Vancomycin group | Active comparator | Drug: vancomycinOral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatients who have symptoms of CDAD as defined by;
- Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study
Key exclusion criteria (14 listed)
- Life-threatening or fulminant CDAD
- Ileus paralytic or toxic megacolon
- Likelihood of death before the completion of study from any cause
- Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD
- The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent
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 |
|---|---|---|
| OPT-80Also: fidaxomicinoral | Drug | OPT-80 group |
| vancomycinoral | Drug | Vancomycin group |
Primary outcome
Global cure rate
Time frame: Up to 38 days
Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period
9 secondary outcomes
Cure rate
Time frame: Day 10 -11 of the study period
Recurrence rate of CDAD
Time frame: during the 4-week follow-up period, up to Day 38
Time to resolution of diarrhea
Time frame: up to 38 days
Microbiological efficacy
Time frame: Up to 38 days
Plasma concentration of OPT-80(fidaxomicin)
Time frame: Before administration, Day 1 and Day 10-11
Plasma concentration of OP-1118
Time frame: Before administration, Day 1 and Day 10-11
Fecal concentration of OPT-80(fidaxomicin)
Time frame: Day 10-11
Fecal concentration of OP-1118
Time frame: Day 10-11
Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests
Time frame: Up to 38 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 29934056Mikamo H, Tateda K, Yanagihara K, Kusachi S, Takesue Y, Miki T, Oizumi Y, Gamo K, Hashimoto A, Toyoshima J, Kato K. Efficacy and safety of fidaxomicin for the treatment of Clostridioides (Clostridium) difficile infection in a randomized, double-blind, comparative Phase III study in Japan. J Infect Chemother. 2018 Sep;24(9):744-752. doi: 10.1016/j.jiac.2018.05.010. Epub 2018 Jun 19.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Clostridium Difficile
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Medical Director study director
Astellas Pharma Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPT-80 and vancomycin in people with Clostridium Difficile, run by Astellas Pharma Inc at 7 sites in Japan.
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 4 inclusion and 14 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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global cure rate (time frame: Up to 38 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 NCT02179658, 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 31 Oct 2024.