Chronic Intestinal Pseudo-obstructionPhase 2NCT04118699
Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial
A Phase 2 study testing Rifaximin oral tablet in people with Chronic Intestinal Pseudo-obstruction, run by Yokohama City University at 1 site in Japan.
Trial summary
The objective of the study is to investigate efficacy and safety of rifaximin (L-105) in patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Chronic Intestinal Pseudo-obstruction
- What is being tested?
- Rifaximin oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 25 Dec 2019to Jan 2022
- Phase
- Phase 2
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients aged ≥20 and <75 on the day of informed consent (IC)
- Patients with CIIPO (designated intractable disease 99) at enrollment, satisfying all the criteria specified in (1) to (7) of the CIIPO Diagnostic Criteria issued in 2014 by the MHLW Research Group, or patients with CIPO, secondary to systemic scleroderma, satisfying all the same criteria specified in (1) to (6)
- Patients' levels of abdominal bloating symptoms, 4 scales of GSS, should be score 2 or 3 at the time of IC acquisition and enrollment.
Who cannot join
- Patients with malignant diseases (excluding those whose symptoms are stable and who do not require aggressive treatments such as chemotherapy and/or surgical therapy)
- Patients with psychiatric diseases (excluding those whose symptoms are stable, and the investigator or coinvestigator concludes that efficacy of the patient can be assessed without any issue)
- Patients with severe diabetes within 5 weeks before enrollment (HbA1c >10%)
- Patients who have already had gastrostomy (including percutaneousendoscopic gastro -jejunostomy, PEG-J), enterostomy, or colostomy
- Patients who underwent intestinal decompression therapy not associated with surgical procedures (trans-nasal ileus tube) within 4weeks before enrollment
- Patients who used antimicrobials, antiparasitics or antifungals (excluding topical use) within 4 weeks before enrollment
Show all 13Show fewer
- Patients who have changed the doses of the following concomitantly administered drugs within 4 weeks before enrollment: mosapride, daikenchuto, metoclopramide, acotiamide
- Patients with severe hepatic disorders within 5 weeks before enrollment (who meet either one of the following criteria: AST≥ 5 x the upper limit of the common reference value specified in the Japanese Committee for Clinical Laboratory Standards (JCCLS), ALT≥ 5 x the upper limit of the common reference value specified in JCCLS, total bilirubin ≥ 3 x the upper limit of the common reference value specified in JCCLS, decompensated hematic cirrhosis, or jaundice)
- Patients who are pregnant, breastfeeding, possibly pregnant, or those who wish to become pregnant
- Patients with a previous history of hypersensitivity to any investigational product ingredients
- Patients with active tuberculosis
- Patients who participated in other clinical trial (including a trial with an investigational product) within 12 weeks before this enrollment and who received an intervention with a test drug
- Other patients whose participation in the trial is concluded to be inappropriate by the investigator or coinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Single Center, Randomized, Placebo Controlled, Double-blind Phase 2 Trial
The objective of the study is to investigate efficacy and safety of rifaximin (L-105) in patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma
Read the detailed description
This is a placebo-controlled, randomized, double-blind, parallel group, comparative study, when patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to the onset of systemic scleroderma, are administered rifaximin at 400 mg 3 times daily for 4 weeks. In addition, the time course of symptoms of the patients are to be confirmed for 8 weeks after the end of administration.
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Being tested
- Rifaximin oral tablet, Placebo oral tablet
- Keywords
- Rifaximin, L-105, phase 2 trial, CIPO, small intestinal bacterial overgrowth, systemic scleroderma
- Medical subject headings
- Intestinal Pseudo-Obstruction, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin oral tabletDrug
Also called L-105
Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered investigational product (rifaximin) for 4 weeks
Placebo oral tabletDrug
Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered placebo for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Two tablets of the investigational product per dosing (400 mg of rifaximin) are orally administered 3 times daily for 4 weeks. Receives: Drug: Rifaximin oral tablet |
| Placebo | Placebo comparator | Two tablets of the placebo are orally administered 3 times daily for 4 weeks. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point Likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms. Score 0 or 1 is defined as improvement.
Measured: at the end of administration (4 weeks)
Improvement ratio (%) in Gastrointestinal (GI) symptoms score
Gastrointestinal score (GI score) is a 5-point Likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms. Score 0 or 1 is defined as improvement.
Measured: at the end of administration (4 weeks)
Secondary outcomes (17)
Changes of the improvement ratio (%) in abdominal bloating score
Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms. Score 0 or 1 is defined as improvement.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of abdominal bloating score
Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the improvement ratio (%) in gastrointestinal symptoms score
Gastrointestinal score (GI score), a 5-point likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms, is used. Score 0 or 1 is defined as improvement.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the "good" ratio (%) in gastrointestinal symptoms score
Gastrointestinal score (GI score), 5-point likert scale (0; very good, 1; good, 2; average, 3; bad, 4; extremely bad), with lower scores reflecting better conditions, is used. Score 0 or 1 is defined as ''good''.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of each score in Global Symptomatic Score other than abdominal bloating score
Global Symptomatic Score (GSS), a 4-point likert scale ranging from 0 (no symptom) to 3 (severe), of the following symptoms are assessed; (a. diarrhea, b. epigastric pain/ discomfort, c. pain in the lower quadrant/discomfort, d. tenderness, e. nausea, f. vomiting).
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of total scores in Global Symptomatic Score
Sum of Global Symptomatic Score (GSS) of the following 7 symptoms, 0 to maximum of 21, are assessed; (a. diarrhea, b. epigastric pain/discomfort, c. abdominal distention, d. pain in the lower quadrant/discomfort, e. tenderness, f. nausea, g. vomiting).
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the improvement ratio (%) in General health condition (symptoms) score
General health condition (symptoms) score, a 5-point likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms, is used. Score 0 or 1 is defined as improvement.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the "good" ratio (%) in General health condition (symptoms) score
General health condition (symptoms) score, 5-point scale (0; very good, 1; good, 2; average, 3; bad, 4; extremely bad), with lower scores reflecting better conditions, is used. Score 0 or 1 is defined as ''good''.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Patient satisfaction score
% of the "satisfaction" ratio in patient satisfaction score
Measured: At the end of the administration (4 weeks)
Changes of Short Form (SF)-8 health survey score
SF-8(short form-8), a self-reporting health survey ranging from 8 to maximum of 42, with lower scores reflecting better conditions, is used.
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Small intestinal volume measured by abdominal CT scan
Changes of small intestinal volume measured by abdominal CT scan
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of serum albumin level
Serum albumin level is calculated for nutritional assessment
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of prealbumin (transthyretin)
Prealbumin (transthyretin) is calculated for nutritional assessment
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of cholinesterase
Cholinesterase is calculated for nutritional assessment
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of folic acid
Folic acid is calculated for nutritional assessment
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of vitamin B12 (cobalamin)
Vitamin B12 (cobalamin) is calculated for nutritional assessment
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of serum iron
Serum iron is calculated for nutritional assessment
Measured: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start25 Dec 2019
- Primary completionNov 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Intestinal Pseudo-obstructionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yokohama City University
- Sponsor type
- University, hospital or other
- Collaborators
- ASKA Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118699
- Sponsor's protocol ID
- YCU19001
- Status last verified
- Jun 2021
- First submitted
- 23 Sep 2019
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohkubo H, Iida H, Takahashi H, Yamada E, Sakai E, Higurashi T, Sekino Y, Endo H, Sakamoto Y, Inamori M, Sato H, Fujimoto K, Nakajima A. An epidemiologic survey of chronic intestinal pseudo-obstruction and evaluation of the newly proposed diagnostic criteria. Digestion. 2012;86(1):12-9. doi: 10.1159/000337528. Epub 2012 Jun 15.
PubMed 22710349Parodi A, Sessarego M, Greco A, Bazzica M, Filaci G, Setti M, Savarino E, Indiveri F, Savarino V, Ghio M. Small intestinal bacterial overgrowth in patients suffering from scleroderma: clinical effectiveness of its eradication. Am J Gastroenterol. 2008 May;103(5):1257-62. doi: 10.1111/j.1572-0241.2007.01758.x. Epub 2008 Apr 16.
PubMed 18422815
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Single Center, Randomized, Placebo Controlled, Double-blind Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04118699
- Acronym / sponsor ID
- YCU19001
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Keywords
- Rifaximin, L-105, phase 2 trial, CIPO, small intestinal bacterial overgrowth, systemic scleroderma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Yokohama City UniversityUniversity, hospital or other
- Collaborators
- ASKA Pharmaceutical Co., Ltd.
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 8 Oct 2019 (actual)
- 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 objective of the study is to investigate efficacy and safety of rifaximin (L-105) in patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma
Detailed description
This is a placebo-controlled, randomized, double-blind, parallel group, comparative study, when patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to the onset of systemic scleroderma, are administered rifaximin at 400 mg 3 times daily for 4 weeks. In addition, the time course of symptoms of the patients are to be confirmed for 8 weeks after the end of administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: Rifaximin oral tabletTwo tablets of the investigational product per dosing (400 mg of rifaximin) are orally administered 3 times daily for 4 weeks. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletTwo tablets of the placebo are orally administered 3 times daily for 4 weeks. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients aged ≥20 and <75 on the day of informed consent (IC)
- Patients with CIIPO (designated intractable disease 99) at enrollment, satisfying all the criteria specified in (1) to (7) of the CIIPO Diagnostic Criteria issued in 2014 by the MHLW Research Group, or patients with CIPO, secondary to systemic scleroderma, satisfying all the same criteria specified in (1) to (6)
- Patients' levels of abdominal bloating symptoms, 4 scales of GSS, should be score 2 or 3 at the time of IC acquisition and enrollment.
Key exclusion criteria (13 listed)
- Patients with malignant diseases (excluding those whose symptoms are stable and who do not require aggressive treatments such as chemotherapy and/or surgical therapy)
- Patients with psychiatric diseases (excluding those whose symptoms are stable, and the investigator or coinvestigator concludes that efficacy of the patient can be assessed without any issue)
- Patients with severe diabetes within 5 weeks before enrollment (HbA1c >10%)
- Patients who have already had gastrostomy (including percutaneousendoscopic gastro -jejunostomy, PEG-J), enterostomy, or colostomy
- Patients who underwent intestinal decompression therapy not associated with surgical procedures (trans-nasal ileus tube) within 4weeks before enrollment
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 |
|---|---|---|
| Rifaximin oral tabletAlso: L-105Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered investigational product (rifaximin) for 4 weeks | Drug | Rifaximin |
| Placebo oral tabletPatients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered placebo for 4 weeks | Drug | Placebo |
Primary outcome
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
Time frame: at the end of administration (4 weeks)
Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point Likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms. Score 0 or 1 is defined as improvement.
Improvement ratio (%) in Gastrointestinal (GI) symptoms score
Time frame: at the end of administration (4 weeks)
Gastrointestinal score (GI score) is a 5-point Likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms. Score 0 or 1 is defined as improvement.
17 secondary outcomes
Changes of the improvement ratio (%) in abdominal bloating score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of abdominal bloating score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the improvement ratio (%) in gastrointestinal symptoms score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the "good" ratio (%) in gastrointestinal symptoms score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of each score in Global Symptomatic Score other than abdominal bloating score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of total scores in Global Symptomatic Score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the improvement ratio (%) in General health condition (symptoms) score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes of the "good" ratio (%) in General health condition (symptoms) score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Patient satisfaction score
Time frame: At the end of the administration (4 weeks)
Changes of Short Form (SF)-8 health survey score
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Small intestinal volume measured by abdominal CT scan
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of serum albumin level
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of prealbumin (transthyretin)
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of cholinesterase
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of folic acid
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of vitamin B12 (cobalamin)
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Changes from baseline of serum iron
Time frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Background: PubMed 22710349Ohkubo H, Iida H, Takahashi H, Yamada E, Sakai E, Higurashi T, Sekino Y, Endo H, Sakamoto Y, Inamori M, Sato H, Fujimoto K, Nakajima A. An epidemiologic survey of chronic intestinal pseudo-obstruction and evaluation of the newly proposed diagnostic criteria. Digestion. 2012;86(1):12-9. doi: 10.1159/000337528. Epub 2012 Jun 15.
- Background: PubMed 18422815Parodi A, Sessarego M, Greco A, Bazzica M, Filaci G, Setti M, Savarino E, Indiveri F, Savarino V, Ghio M. Small intestinal bacterial overgrowth in patients suffering from scleroderma: clinical effectiveness of its eradication. Am J Gastroenterol. 2008 May;103(5):1257-62. doi: 10.1111/j.1572-0241.2007.01758.x. Epub 2008 Apr 16.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifaximin oral tablet in people with Chronic Intestinal Pseudo-obstruction, run by Yokohama City University at 1 site 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS) (time frame: at the end of administration (4 weeks)). The study lists 2 primary outcomes in all. 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 NCT04118699, which also lists 2 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 21 Jun 2021.