Enterocolitis Clostridium Difficile RecurrentPhase 2PUNCHCD2NCT02299570
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
A Phase 2 study testing RBX2660 (microbiota suspension) in people with Enterocolitis Clostridium Difficile Recurrent, run by Rebiotix Inc. at 21 sites in 2 countries.
Trial summary
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterocolitis Clostridium Difficile Recurrent
- What is being tested?
- RBX2660 (microbiota suspension)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Dec 2014to Jan 2018
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
- Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
- A positive stool test for the presence of C. difficile within 60 days prior to enrollment.
Who cannot join
- A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
- Requires antibiotic therapy for a condition other than recurrent CDI.
- Previous fecal transplant prior to study enrollment.
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of irritable bowel syndrome (IBS).
- History of chronic diarrhea.
Show all 11Show fewer
- History of celiac disease.
- Colostomy.
- Planned surgery requiring perioperative antibiotics within 6 months of study enrollment.
- Life expectancy of < 12 months.
- Compromised immune system.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
University of Colorado
Aurora, Colorado, 80045
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Loyola University Chicago
Chicago, Illinois, 60153
University of Chicago
Chicago, Illinois, 60637
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
Henry Ford Health System
Detroit, Michigan, 48202
Sanford Health
Fargo, North Dakota, 58122
New York Hospital Queens
Flushing, New York, 11355
Grand Teton Research Group
Idaho Falls, Idaho, 83404
Infectious Diseases of Indiana
Indianapolis, Indiana, 46260
Borland-Groover Clinic
Jacksonville, Florida, 32256
Regional Infectious Diseases and Infusion Center
Lima, Ohio, 45801
New York-Presbyterian Hospital/Weill Cornell Medical College
New York, New York, 10065
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Gastroenterology Group of Rochester
Rochester, New York, 14618
Regions Hospital
Saint Paul, Minnesota, 55101
Washington University School of Medicine
St Louis, Missouri, 63110
Canada2 sites
St. Joseph's Hospital
Hamilton, Ontario, L8N 4A6
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Read the detailed description
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
- Being tested
- RBX2660 (microbiota suspension), Placebo
- Keywords
- Clostridium difficile, C diff, CDI, CDAD, Fecal transplant, Fecal Microbiota Transplant, Diarrhea, FMT, Microbiota restoration therapy, Microbiota suspension, Fecal bacteriotherapy, C diff diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBX2660 (microbiota suspension)Biological
A suspension of intestinal microbes
PlaceboOther
A suspension of saline and cryoprotectant
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Two enemas of RBX2660 (microbiota suspension) administered 7 days apart Receives: Biological: RBX2660 (microbiota suspension) |
| Group B | Placebo comparator | Two enemas of placebo administered 7 days apart Receives: Other: Placebo |
| Group C | Active comparator | 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart Receives: Biological: RBX2660 (microbiota suspension); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
Measured: 8 weeks after last assigned study treatment
Secondary outcomes (6)
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
Measured: 8-weeks
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
Measured: 8-weeks
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT)
The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
Measured: 8-week
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Measured: 8-weeks
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Measured: 8-weeks
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2016
- Study completionJan 2018
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 (8)Papers the sponsor has linked to this study.
- Other trials for Enterocolitis Clostridium Difficile RecurrentStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebiotix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teena Chopra, MD MPH, Study chair, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299570
- Sponsor's protocol ID
- 2014-01
- Acronym
- PUNCHCD2
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2014
- Last updated
- 15 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Moayyedi P, Marshall JK, Yuan Y, Hunt R. Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy. Can J Gastroenterol Hepatol. 2014 Feb;28(2):66-8. doi: 10.1155/2014/346590. No abstract available.
PubMed 25232572Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
PubMed 22002980Chopra T, Van Handel D, Baggott B, Orenstein R, Reveles K, Guthmueller B, Srivastava S, Khanna S. Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies. Infect Dis Ther. 2026 Aug;15(8):2071-2086. doi: 10.1007/s40121-026-01374-9. Epub 2026 Jun 12.
PubMed 42286373Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Ther Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.
PubMed 41245385Dubberke ER, Orenstein R, Khanna S, Guthmueller B, Lee C. Final Results from a Phase 2b Randomized, Placebo-Controlled Clinical Trial of RBX2660: A Microbiota-Based Drug for the Prevention of Recurrent Clostridioides difficile Infection. Infect Dis Ther. 2023 Feb;12(2):703-709. doi: 10.1007/s40121-022-00744-3. Epub 2022 Dec 21.
PubMed 36544075Kwak S, Choi J, Hink T, Reske KA, Blount K, Jones C, Bost MH, Sun X, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial. Microbiome. 2020 Aug 31;8(1):125. doi: 10.1186/s40168-020-00907-9.
PubMed 32862830Dubberke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerding DN. Results From a Randomized, Placebo-Controlled Clinical Trial of a RBX2660-A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection. Clin Infect Dis. 2018 Sep 28;67(8):1198-1204. doi: 10.1093/cid/ciy259.
PubMed 29617739
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study Demonstrating the Efficacy and Safety of Rebiotix RBX2660 (Microbiota Suspension) for the Treatment of Recurrent Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02299570
- Acronym / sponsor ID
- PUNCHCD2 / 2014-01
- Keywords
- Clostridium difficile, C diff, CDI, CDAD, Fecal transplant, Fecal Microbiota Transplant, Diarrhea, FMT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rebiotix Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 27 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Detailed description
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: RBX2660 (microbiota suspension)Two enemas of RBX2660 (microbiota suspension) administered 7 days apart |
| Group B | Placebo comparator | Other: PlaceboTwo enemas of placebo administered 7 days apart |
| Group C | Active comparator | Biological: RBX2660 (microbiota suspension), Other: Placebo1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years
- Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization.
- Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics.
- A positive stool test for the presence of C. difficile within 60 days prior to enrollment.
Key exclusion criteria (11 listed)
- A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment.
- Requires antibiotic therapy for a condition other than recurrent CDI.
- Previous fecal transplant prior to study enrollment.
- History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis.
- History of irritable bowel syndrome (IBS).
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 |
|---|---|---|
| RBX2660 (microbiota suspension)A suspension of intestinal microbes | Biological | Group A, Group C |
| PlaceboA suspension of saline and cryoprotectant | Other | Group B, Group C |
Primary outcome
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
Time frame: 8 weeks after last assigned study treatment
The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
6 secondary outcomes
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Time frame: 8-weeks
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
Time frame: 8-weeks
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT)
Time frame: 8-week
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
Time frame: 8-weeks
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
Time frame: 8-weeks
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
Time frame: 8-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23323867van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
- Background: PubMed 25232572Moayyedi P, Marshall JK, Yuan Y, Hunt R. Canadian Association of Gastroenterology position statement: fecal microbiota transplant therapy. Can J Gastroenterol Hepatol. 2014 Feb;28(2):66-8. doi: 10.1155/2014/346590. No abstract available.
- Background: PubMed 22002980Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.
- Derived from this study: PubMed 42286373Chopra T, Van Handel D, Baggott B, Orenstein R, Reveles K, Guthmueller B, Srivastava S, Khanna S. Efficacy Outcomes of Fecal Microbiota, Live-jslm in Preventing Recurrent Clostridioides difficile Infection from Seven Clinical Studies. Infect Dis Ther. 2026 Aug;15(8):2071-2086. doi: 10.1007/s40121-026-01374-9. Epub 2026 Jun 12.
- Derived from this study: PubMed 41245385Lee C, Feuerstadt P, Louie T, Bancke L, Guthmueller B, Harvey A, Hoeyer F, Orenstein R, Dubberke ER, Khanna S. Integrated analysis of the safety of fecal microbiota, live-jslm in adults with recurrent Clostridioides difficile infection from five prospective clinical trials: an update. Ther Adv Gastroenterol. 2025 Nov 12;18:17562848251395566. doi: 10.1177/17562848251395566. eCollection 2025.
- Derived from this study: PubMed 36544075Dubberke ER, Orenstein R, Khanna S, Guthmueller B, Lee C. Final Results from a Phase 2b Randomized, Placebo-Controlled Clinical Trial of RBX2660: A Microbiota-Based Drug for the Prevention of Recurrent Clostridioides difficile Infection. Infect Dis Ther. 2023 Feb;12(2):703-709. doi: 10.1007/s40121-022-00744-3. Epub 2022 Dec 21.
- Derived from this study: PubMed 32862830Kwak S, Choi J, Hink T, Reske KA, Blount K, Jones C, Bost MH, Sun X, Burnham CD, Dubberke ER, Dantas G; CDC Prevention Epicenter Program. Impact of investigational microbiota therapeutic RBX2660 on the gut microbiome and resistome revealed by a placebo-controlled clinical trial. Microbiome. 2020 Aug 31;8(1):125. doi: 10.1186/s40168-020-00907-9.
- Derived from this study: PubMed 29617739Dubberke ER, Lee CH, Orenstein R, Khanna S, Hecht G, Gerding DN. Results From a Randomized, Placebo-Controlled Clinical Trial of a RBX2660-A Microbiota-Based Drug for the Prevention of Recurrent Clostridium difficile Infection. Clin Infect Dis. 2018 Sep 28;67(8):1198-1204. doi: 10.1093/cid/ciy259.
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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.
Teena Chopra, MD MPH study chair
Wayne State University
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBX2660 (microbiota suspension) in people with Enterocolitis Clostridium Difficile Recurrent, run by Rebiotix Inc. at 21 sites in 2 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 4 inclusion and 11 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 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Jul 2018). 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?
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) (time frame: 8 weeks after last assigned study treatment). 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 NCT02299570, which also lists 8 linked publications.
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 15 Jan 2021.