DyspepsiaNCT00437346
Functional Dyspepsia - Effect of Acid-Reducing Treatment and Information.
A study testing Individualized and comprehensive information and Lanzo Melt in people with Dyspepsia, run by Helse Fonna at 5 sites in Norway.
Trial summary
Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized information. Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be present. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Individualized and comprehensive information and Lanzo Melt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesNorway
- Study dates
- Jan 2007to Jul 2016
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20 - 60 years
- Rome II criteria fulfilled
- Helicobacter test negative (urease-test)
- Informed consent
Who cannot join
- Diabetes
- Prior gastrointestinal surgery
- Treatment with proton pump inhibitors / H2 blockers the last 30 days
- Pregnancy / lactation
- Current use of NSAIDs
- Serious psychiatric illness
- Serious egg allergy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Department of Medicine, Haugesund Hospital
Haugesund, N-5504
Department of Medisin, Haugesund Hospital
Haugesund, N-5504
Department of Radiology, Haugesund Hospital
Haugesund, N-5504
Surgical Department, Haugesund Hospital
Haugesund, N-5504
Gastro-group
Haugesund, N-5527
About this study
Official title: Study of Gastroscopy Negative Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility.
Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized information.
Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be present. The most important relevant medical examination is gastroscopy, and if the findings are normal the condition is usually classified as functional dyspepsia.
Read more
Several disturbances of function are now known as potential causes of such symptoms, and the optimal choice of treatment may vary.
In the study the investigators plan to examine whether different types of functional disturbances respond differently to medical therapy. In particular, the investigators want to assess whether comprehensive and individualized information will influence the results of therapy. This has not been previously studied systematically.
The investigators also postulate that disturbances of function of the esophagus may cause complaints that should be classified as functional dyspepsia even if the symptoms are atypical. Few studies have been done to evaluate this hypothesis, and there may be potential consequences for choice of appropriate treatment.
In animal models and in humans is recently demonstrated that elevated gastric pH because of anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study and eventually development of food allergy will influence patient's condition in an observations period. That why we're observing IgE dynamics in our study.
Read the detailed description
Purpose
Functional dyspepsia is a common disorder affecting approximately 25 % of the adult population. Functional dyspepsia is defined from symptoms according to the Rome II criteria. A normal upper endoscopy is also warranted Many of these patients have specific motility disorders. A more accurate diagnosis could mean a more effective treatment.
In this study the patients take several tests in order to make a more specific diagnosis. These include: 24 hour pH-monitoring, oesophagusmanometry, drink test and scintigrafy.
We will study the effect of acid reducing treatment (proton pump inhibitors) on the different dysmotility-types and also the effect of medical information and advise.
We will observe concentrations of total IgE and various specific antibodies against food allergens in serum when taking PPI. Results here can vary dependent on whether the patient has used PPI anytime before or not.
Patients
The patients are included via referrals from general practitioners and hospital doctors. An upper endoscopy is performed. If this investigation is normal the patient is considered for inclusion in the study.
Criteria for inclusion are
- Age 20 - 60 years
- Rome II criteria fulfilled
- Helicobacter test negative (urease-test)
- Informed consent
Criteria for exclusion are
- Diabetes
- Prior gastrointestinal surgery
- Treatment with proton pump inhibitors / H2 blockers the last 30 days
- Pregnancy / lactation
- Current use of NSAIDs
- Serious psychiatric illness
- Serious egg-allergy
Study design
Start of the study: symptom score based on symptoms within the last three days. Lanzo melt 30 mg daily is given as a morning dose. Patients are randomized in two groups. Group A is given thorough information based on the tests taken plus medical treatment. Group B receives medical treatment only.
After two weeks symptom score per telephone. After four weeks a new symptom score. A reduction by at least 25 % is defined as treatment response. These patients continue their medical treatment for three months. Now all patients receive thorough information.
Non responders end their medical treatment and they are followed with medical information and advise the next three months.
After eight weeks symptom score per telephone. After 12 weeks symptom score per telephone. After 16 weeks the study is ended. Symptom score is taken.
After 4 and 16 weeks the patient evaluates his/her treatment in five categories: Very satisfied, satisfied, less satisfied, no change, worse.
Symptom score
Seven symptoms are scored from 1-7 points based on the last week. The symptoms are: regurgitation, nausea, early satiety, belching, pain referred to meals, pain not referred to meals, postprandial fullness.
- No symptoms
- Insignificant symptoms (as usual ignored)
- Light symptoms (easy to ignore)
- Moderate symptoms (easy to tolerate)
- Quite marked symptoms (not easy to tolerate)
- Marked symptoms (affects daily activities)
- Substantional symptoms (can't do daily activities)
24 hour pH monitoring
Digitrapper III from Synectics is used. A probe is installed trans nasally to the gastric lumen where a pH value is registered. Afterwards the probe is placed five cm over the upper border of the lower esophageal sphincter (LES). After 24 hours registration is completed and analyzed with the use of Polygram 98 from Medtronic Functional Diagnostics AS.
Total reflux index, reflux with meals, postprandial reflux, nightly reflux and long reflux episodes are registered. Pathologic reflux index is defined as pathological if reflux is over 5 %.
Acid Clearence Time (ACT) is also estimated. It is found by dividing total reflux time with the number of refluxes. Upper normal limit is set to 0,85 minutes/reflux.
Esophagusmanometry
We use perfusion manometry. The catheter has sensors in five levels five cm apart. LES is first localized and length and resting pressure are registered. We test for normal relaxation with swallowing. Then we test the motility (peristalsis and amplitude/duration of pressure waves).
Scintigraphy
We give a standard meal composed of two omelets, one slice of bread and a glass of water. Radioactive Technesium is injected into the omelet and the meal is eaten in ten minutes. Picture uptakes are taken according to the protocol the first hour after completion of the meal. Gastric emptying time is estimated.
Drink test The patients drink water 150 ml/min until they feel they must stop. Symptoms are registered when they stop and 15 and 30 minutes there after. This is a test to determine accommodation and visceral sensibility.
Blood tests Hemoglobin, sedimentation rate, CRP, leucocytes, thrombocytes, bilirubin, ALP, ALAT, g-GT, albumin and amylase are taken to exclude organic disease. It does not represent a variable in the study design.
- Conditions
- Dyspepsia
- Being tested
- Individualized and comprehensive information, Lanzo Melt
- Keywords
- dyspepsia, functional dyspepsia, treatment, drug therapy, information
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized and comprehensive informationProcedure or surgery
Thorough verbal and written information about results of the tests. Individualized meals recommendation based on the results.
Lanzo MeltDrug
30mg, od, 1/2 h before meal
Lanzo MeltDrug
30mg, od, 1/2 h before meal
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients is given thorough information based on the tests taken plus medical treatment. Receives: Procedure: Individualized and comprehensive information; Drug: Lanzo Melt |
| Group B | Active comparator | Patients receive simple written information based on the tests taken plus medical treatment. Receives: Drug: Lanzo Melt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptom score
Measured: november 2009-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: The project leader left our hospital and the project were shut down.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helge Børresen, Helse Fonna
- Investigators
- Valerij Glazkov, MD, Principal investigator, Department of Medicine, Haugesund Hospital, N-5504 Haugesund, NorwayJan G. Hatlebakk, MD, PhD, Study chair, Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437346
- Sponsor's protocol ID
- 15312
- Status last verified
- Dec 2019
- First submitted
- 15 Feb 2007
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II37-42. doi: 10.1136/gut.45.2008.ii37.
PubMed 10457043Tack J, Bisschops R, Sarnelli G. Pathophysiology and treatment of functional dyspepsia. Gastroenterology. 2004 Oct;127(4):1239-55. doi: 10.1053/j.gastro.2004.05.030. No abstract available.
PubMed 15481001Talley NJ, Verlinden M, Jones M. Can symptoms discriminate among those with delayed or normal gastric emptying in dysmotility-like dyspepsia? Am J Gastroenterol. 2001 May;96(5):1422-8. doi: 10.1111/j.1572-0241.2001.03683.x.
PubMed 11374677Talley NJ, Locke GR, Lahr BD, Zinsmeister AR, Cohard-Radice M, D'Elia TV, Tack J, Earnest DL. Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther. 2006 Apr 1;23(7):923-36. doi: 10.1111/j.1365-2036.2006.02845.x.
PubMed 16573795Bolling-Sternevald E, Lauritsen K, Aalykke C, Havelund T, Knudsen T, Unge P, Ekstrom P, Jaup B, Norrby A, Stubberod A, Melen K, Carlsson R, Jerndal P, Junghard O, Glise H. Effect of profound acid suppression in functional dyspepsia: a double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol. 2002 Dec;37(12):1395-402. doi: 10.1080/003655202762671260.
PubMed 12523588Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the management of dyspepsia. Am J Gastroenterol. 2005 Oct;100(10):2324-37. doi: 10.1111/j.1572-0241.2005.00225.x.
PubMed 16181387Jones MP, Roth LM, Crowell MD. Symptom reporting by functional dyspeptics during the water load test. Am J Gastroenterol. 2005 Jun;100(6):1334-9. doi: 10.1111/j.1572-0241.2005.40802.x.
PubMed 15929766Untersmayr E, Jensen-Jarolim E. The effect of gastric digestion on food allergy. Curr Opin Allergy Clin Immunol. 2006 Jun;6(3):214-9. doi: 10.1097/01.all.0000225163.06016.93.
PubMed 16670517
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Gastroscopy Negative Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility.
- ClinicalTrials.gov ID
- NCT00437346
- Acronym / sponsor ID
- 15312
- Conditions
- Dyspepsia
- Keywords
- dyspepsia, functional dyspepsia, treatment, drug therapy, information
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The project leader left our hospital and the project were shut down.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Feb 2007 (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.
Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized information.
Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be present. The most important relevant medical examination is gastroscopy, and if the findings are normal the condition is usually classified as functional dyspepsia.
Several disturbances of function are now known as potential causes of such symptoms, and the optimal choice of treatment may vary.
In the study the investigators plan to examine whether different types of functional disturbances respond differently to medical therapy. In particular, the investigators want to assess whether comprehensive and individualized information will influence the results of therapy. This has not been previously studied systematically.
The investigators also postulate that disturbances of function of the esophagus may cause complaints that should be classified as functional dyspepsia even if the symptoms are atypical. Few studies have been done to evaluate this hypothesis, and there may be potential consequences for choice of appropriate treatment.
In animal models and in humans is recently demonstrated that elevated gastric pH because of anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study and eventually development of food allergy will influence patient's condition in an observations period. That why we're observing IgE dynamics in our study.
Detailed description
Purpose
Functional dyspepsia is a common disorder affecting approximately 25 % of the adult population. Functional dyspepsia is defined from symptoms according to the Rome II criteria. A normal upper endoscopy is also warranted Many of these patients have specific motility disorders. A more accurate diagnosis could mean a more effective treatment.
In this study the patients take several tests in order to make a more specific diagnosis. These include: 24 hour pH-monitoring, oesophagusmanometry, drink test and scintigrafy.
We will study the effect of acid reducing treatment (proton pump inhibitors) on the different dysmotility-types and also the effect of medical information and advise.
We will observe concentrations of total IgE and various specific antibodies against food allergens in serum when taking PPI. Results here can vary dependent on whether the patient has used PPI anytime before or not.
Patients
The patients are included via referrals from general practitioners and hospital doctors. An upper endoscopy is performed. If this investigation is normal the patient is considered for inclusion in the study.
Criteria for inclusion are
- Age 20 - 60 years
- Rome II criteria fulfilled
- Helicobacter test negative (urease-test)
- Informed consent
Criteria for exclusion are
- Diabetes
- Prior gastrointestinal surgery
- Treatment with proton pump inhibitors / H2 blockers the last 30 days
- Pregnancy / lactation
- Current use of NSAIDs
- Serious psychiatric illness
- Serious egg-allergy
Study design
Start of the study: symptom score based on symptoms within the last three days. Lanzo melt 30 mg daily is given as a morning dose. Patients are randomized in two groups. Group A is given thorough information based on the tests taken plus medical treatment. Group B receives medical treatment only.
After two weeks symptom score per telephone. After four weeks a new symptom score. A reduction by at least 25 % is defined as treatment response. These patients continue their medical treatment for three months. Now all patients receive thorough information.
Non responders end their medical treatment and they are followed with medical information and advise the next three months.
After eight weeks symptom score per telephone. After 12 weeks symptom score per telephone. After 16 weeks the study is ended. Symptom score is taken.
After 4 and 16 weeks the patient evaluates his/her treatment in five categories: Very satisfied, satisfied, less satisfied, no change, worse.
Symptom score
Seven symptoms are scored from 1-7 points based on the last week. The symptoms are: regurgitation, nausea, early satiety, belching, pain referred to meals, pain not referred to meals, postprandial fullness.
- No symptoms
- Insignificant symptoms (as usual ignored)
- Light symptoms (easy to ignore)
- Moderate symptoms (easy to tolerate)
- Quite marked symptoms (not easy to tolerate)
- Marked symptoms (affects daily activities)
- Substantional symptoms (can't do daily activities)
24 hour pH monitoring
Digitrapper III from Synectics is used. A probe is installed trans nasally to the gastric lumen where a pH value is registered. Afterwards the probe is placed five cm over the upper border of the lower esophageal sphincter (LES). After 24 hours registration is completed and analyzed with the use of Polygram 98 from Medtronic Functional Diagnostics AS.
Total reflux index, reflux with meals, postprandial reflux, nightly reflux and long reflux episodes are registered. Pathologic reflux index is defined as pathological if reflux is over 5 %.
Acid Clearence Time (ACT) is also estimated. It is found by dividing total reflux time with the number of refluxes. Upper normal limit is set to 0,85 minutes/reflux.
Esophagusmanometry
We use perfusion manometry. The catheter has sensors in five levels five cm apart. LES is first localized and length and resting pressure are registered. We test for normal relaxation with swallowing. Then we test the motility (peristalsis and amplitude/duration of pressure waves).
Scintigraphy
We give a standard meal composed of two omelets, one slice of bread and a glass of water. Radioactive Technesium is injected into the omelet and the meal is eaten in ten minutes. Picture uptakes are taken according to the protocol the first hour after completion of the meal. Gastric emptying time is estimated.
Drink test The patients drink water 150 ml/min until they feel they must stop. Symptoms are registered when they stop and 15 and 30 minutes there after. This is a test to determine accommodation and visceral sensibility.
Blood tests Hemoglobin, sedimentation rate, CRP, leucocytes, thrombocytes, bilirubin, ALP, ALAT, g-GT, albumin and amylase are taken to exclude organic disease. It does not represent a variable in the study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Individualized and comprehensive information, Drug: Lanzo MeltPatients is given thorough information based on the tests taken plus medical treatment. |
| Group B | Active comparator | Drug: Lanzo MeltPatients receive simple written information based on the tests taken plus medical treatment. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20 - 60 years
- Rome II criteria fulfilled
- Helicobacter test negative (urease-test)
- Informed consent
Key exclusion criteria (7 listed)
- Diabetes
- Prior gastrointestinal surgery
- Treatment with proton pump inhibitors / H2 blockers the last 30 days
- Pregnancy / lactation
- Current use of NSAIDs
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 |
|---|---|---|
| Individualized and comprehensive informationThorough verbal and written information about results of the tests. Individualized meals recommendation based on the results. | Procedure or surgery | Group A |
| Lanzo Melt30mg, od, 1/2 h before meal | Drug | Group A |
| Lanzo Melt30mg, od, 1/2 h before meal | Drug | Group B |
Primary outcome
Improvement of symptom score
Time frame: november 2009-2013
Results and safety
The study was stopped early (reason given: The project leader left our hospital and the project were shut down.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 10457043Talley NJ, Stanghellini V, Heading RC, Koch KL, Malagelada JR, Tytgat GN. Functional gastroduodenal disorders. Gut. 1999 Sep;45 Suppl 2(Suppl 2):II37-42. doi: 10.1136/gut.45.2008.ii37.
- Background: PubMed 15481001Tack J, Bisschops R, Sarnelli G. Pathophysiology and treatment of functional dyspepsia. Gastroenterology. 2004 Oct;127(4):1239-55. doi: 10.1053/j.gastro.2004.05.030. No abstract available.
- Background: PubMed 11374677Talley NJ, Verlinden M, Jones M. Can symptoms discriminate among those with delayed or normal gastric emptying in dysmotility-like dyspepsia? Am J Gastroenterol. 2001 May;96(5):1422-8. doi: 10.1111/j.1572-0241.2001.03683.x.
- Background: PubMed 16573795Talley NJ, Locke GR, Lahr BD, Zinsmeister AR, Cohard-Radice M, D'Elia TV, Tack J, Earnest DL. Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther. 2006 Apr 1;23(7):923-36. doi: 10.1111/j.1365-2036.2006.02845.x.
- Background: PubMed 12523588Bolling-Sternevald E, Lauritsen K, Aalykke C, Havelund T, Knudsen T, Unge P, Ekstrom P, Jaup B, Norrby A, Stubberod A, Melen K, Carlsson R, Jerndal P, Junghard O, Glise H. Effect of profound acid suppression in functional dyspepsia: a double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol. 2002 Dec;37(12):1395-402. doi: 10.1080/003655202762671260.
- Background: PubMed 16181387Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the management of dyspepsia. Am J Gastroenterol. 2005 Oct;100(10):2324-37. doi: 10.1111/j.1572-0241.2005.00225.x.
- Background: PubMed 15929766Jones MP, Roth LM, Crowell MD. Symptom reporting by functional dyspeptics during the water load test. Am J Gastroenterol. 2005 Jun;100(6):1334-9. doi: 10.1111/j.1572-0241.2005.40802.x.
- Background: PubMed 16670517Untersmayr E, Jensen-Jarolim E. The effect of gastric digestion on food allergy. Curr Opin Allergy Clin Immunol. 2006 Jun;6(3):214-9. doi: 10.1097/01.all.0000225163.06016.93.
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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.
Valerij Glazkov, MD principal investigator
Department of Medicine, Haugesund Hospital, N-5504 Haugesund, Norway
Jan G. Hatlebakk, MD, PhD study chair
Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized and comprehensive information and Lanzo Melt in people with Dyspepsia, run by Helse Fonna at 5 sites in Norway.
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 7 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: stopped early, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. 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.
Are results available for this study?
The study was stopped early (reason given: The project leader left our hospital and the project were shut down.). 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 of symptom score (time frame: november 2009-2013). 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 NCT00437346, 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 16 Dec 2019.