Renal ColicNCT05150899
Role of Antihistaminic in Acute Renal Colic Prevent Pain Recurrence and Expulsion of Ureteric Stone ≤ 1cm
An observational study of Renal Colic and Ureter Stone, run by Assiut University.
Trial summary
Urolithiasis is one of the most common urological diseases. The risk of stone disease ranges between 5% and 12% worldwide. Ureteric stones account for ≈20% of all urinary tract stones and >70% of the ureteric stones are located in the lower third of the ureter, i.e., distal ureteric stones (DUS). Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Colic, Ureter Stone
- What is being tested?
- Tamsulosin Hcl 0.4Mg Cap and fexofenadine 180 mg Oral tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2021to 25 Nov 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non-probability sample size) with Confidence Level 90 %, Population Size 10000, Margin of Error 8 % with expected size of 100 patients enrolled in the study. these patients were randomly divided into 2 groups 50 in each group.
Who may be able to join
- Age from 14 to 70 years old.
- Patient with ureteric stone 5-10 MM.
- Patient with acute renal colic presented to emergency with obstructed kidney with urgent MSCT show stone ureter 5-10 MM and patient come without colic with CT showing lower third stone of the same measurement.
Who cannot join
- Age less than 14 or more than 70.
- Chronically diseased patient cardiac that contraindicated to take PD5I or tamsulosin.
- Only functioning kidney.
- CKD Patient.
- Bilateral ureteric stone.
- urinary tract infection.
Show all 14Show fewer
- severe refractory pain.
- severe hydronephrosis.
- multiple ureteric stones.
- ischemic heart disease, congestive cardiac failure, or complicated hypertension.
- pregnant or lactating mothers.
- patient refuse medical treatment.
- congenital anomalies.
- previous ureteric surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Use of Alpha Blocker Versus Alpha Blocker and Antihistaminic in Management of Acute Renal Colic Prevent Pain Recurrence and Increase Expulsion Rate of Ureteric Stone ≤ 1cm
Urolithiasis is one of the most common urological diseases. The risk of stone disease ranges between 5% and 12% worldwide. Ureteric stones account for ≈20% of all urinary tract stones and >70% of the ureteric stones are located in the lower third of the ureter, i.e., distal ureteric stones (DUS). The colicky-type pain in the ureter, an increase in proximal peristalsis through activation of intrinsic ureteral pacemakers may contribute to the perception of pain. Muscle spasm increased proximal peristalsis, local inflammation, irritation, and oedema at the site of obstruction may contribute to the development of pain through chemoreceptor activation and stretching of submucosal free nerve endings. α-adrenergic blockers, anti-inflammatory drugs, antihistaminic and calcium channel blockers, which have a relaxant effect on the ureteric smooth musculature. The presence of histamine receptors in the ureter have been presented in various studies. The histamine-1 (H1) receptors have been shown to have a wide distribution Histamine, which is secreted from the mast cells, causes strong peristaltic contractions in the ureter. alpha adrenoreceptor antagonists (i.e., tamsulosin) have been employed in the treatment of ureteric colic due to smooth muscle relaxation so their potential ability to increase stone passage, reduce pain medication use and reduce urologic interventions. According to the currently accepted view, renal colic management starts with NSAI drugs also NSAI has role in decrease inflammation and oedema and increase expulsion rate . in this study we will compare the use of alpha blocker versus alpha blocker and antihistaminic in management of acute renal colic prevent pain recurrence and increase expulsion rate of ureteric stone ≤ 1cm, with analgesic use in case of acute stage.
Read the detailed description
All the patients will be included within inclusion criteria After providing written informed consent, these patients were randomly divided into 2 groups by use of a computer-generated random number table.
- history taken about patient pain onset, duration and type with scoring the pain by World Health Organization numerical pain score of 0-10.
- Ultrasonography done to determine if kidney obstructed and grade of obstruction at the day 1 day 15 and day 30.
- group A receive Tamsulosin 0.4mg in combination of NSAI drug if patient present with colic, if not in renal colic at bed time Tamsulosin 0.4mg with analgesic on demand, group B receive pheniramine maleate 50mg injection every 12hr for 24 hr in combination of Tamsulosin 0.4mg and NSAI drug then fexofenadine 180 mg in combination of Tamsulosin 0.4mg and NSAI drug on demand if patient present with colic. if not in renal colic at bed time fexofenadine 180 mg in combination of Tamsulosin with NSAI on demand.
- In case of patient presented by acute renal colic the time of administration of treatment recorded and the time of relief pain recorded.
- CT scan done to ensure urolithiases if no CT done at the first day and after 30 days.
- Full labs done especially serum creatinine and serum uric acid.
- Conditions
- Renal Colic, Ureter Stone
- Being tested
- Tamsulosin Hcl 0.4Mg Cap, fexofenadine 180 mg Oral tablet
- Medical subject headings
- Renal Colic, Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin Hcl 0.4Mg CapDrug
Also called tamsule
alpha blocker
fexofenadine 180 mg Oral tabletDrug
Also called telefast
antihistaminic
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin 0.4mg | group A receive Tamsulosin 0.4mg in combination of NSAI drug if patient present with colic, if not in renal colic at bed time Tamsulosin 0.4mg with analgesic on demand. Receives: Drug: Tamsulosin Hcl 0.4Mg Cap | |
| fexofenadine 180 mg in combination of Tamsulosin 0.4mg | group B receive pheniramine maleate 50mg injection every 12hr for 24 hr in combination of Tamsulosin 0.4mg and NSAI drug then fexofenadine 180 mg in combination of Tamsulosin 0.4mg and NSAI drug on demand if patient present with colic. if not in renal colic at bed time fexofenadine 180 mg in combination of Tamsulosin with NSAI on demand. Receives: Drug: Tamsulosin Hcl 0.4Mg Cap; Drug: fexofenadine 180 mg Oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of each treatment in case of patient presented with acute renal colic
(% of patients show relief of the pain).
Measured: 3 weeks
Duration of relieve of the symptoms
relieve of renal colic
Measured: in 24 hours
Rate of recurrence of pain and if need analgesic
how many times pain come again
Measured: 3 weeks
Numbers of patients showing expulsion of stone
how many people stone expulsed during treatment
Measured: 3 weeks
Number of patients underwent URS and duration taken from start of treatment
patient with persistent pain
Measured: 3 weeks
Rate of complication from treatment
any side effect from treatment
Measured: 3 weeks
Rate of hospital admission and number of admissions.
due to persistent pain
Measured: 3 weeks
Rate of drop out from the study due to complication or noncompliance.
patient exit from study
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start30 Nov 2021 (estimated)
- Primary completion25 Nov 2022 (estimated)
- Study completion25 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kamel Abdel Rahman, Assiut University
- Investigators
- adel kurkar, MD, Principal investigator, Assiut Universitymostafa kamel, demonstrator, Principal investigator, Assiut Universityahmed eltaher, MD, Study chair, Assiut Universityahmed elbadry, MD, Study chair, Assiut Universityahmed abdelhameed, MD, Study chair, Assiut Universityrabee gadelkareem, MD, Study chair, Assiut Universityhosney behnsawy, MD, Study chair, Assiut Universitymohamed zarzour, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150899
- Sponsor's protocol ID
- antihistaminic in renal colic
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bader MJ, Eisner B, Porpiglia F, Preminger GM, Tiselius HG. Contemporary management of ureteral stones. Eur Urol. 2012 Apr;61(4):764-72. doi: 10.1016/j.eururo.2012.01.009. Epub 2012 Jan 14.
PubMed 22266271Coll DM, Varanelli MJ, Smith RC. Relationship of spontaneous passage of ureteral calculi to stone size and location as revealed by unenhanced helical CT. AJR Am J Roentgenol. 2002 Jan;178(1):101-3. doi: 10.2214/ajr.178.1.1780101.
PubMed 11756098Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT, Hollenbeck BK. Medical therapy to facilitate urinary stone passage: a meta-analysis. Lancet. 2006 Sep 30;368(9542):1171-9. doi: 10.1016/S0140-6736(06)69474-9.
PubMed 17011944Giuliano F, Uckert S, Maggi M, Birder L, Kissel J, Viktrup L. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):506-16. doi: 10.1016/j.eururo.2012.09.006. Epub 2012 Sep 11.
PubMed 23018163Gratzke C, Uckert S, Kedia G, Reich O, Schlenker B, Seitz M, Becker AJ, Stief CG. In vitro effects of PDE5 inhibitors sildenafil, vardenafil and tadalafil on isolated human ureteral smooth muscle: a basic research approach. Urol Res. 2007 Feb;35(1):49-54. doi: 10.1007/s00240-006-0073-1. Epub 2006 Nov 11.
PubMed 17102958Kumar S, Jayant K, Agrawal MM, Singh SK, Agrawal S, Parmar KM. Role of tamsulosin, tadalafil, and silodosin as the medical expulsive therapy in lower ureteric stone: a randomized trial (a pilot study). Urology. 2015 Jan;85(1):59-63. doi: 10.1016/j.urology.2014.09.022.
PubMed 25530364Ugaily-Thulesius L, Thulesius O. The effects of urine on mast cells and smooth muscle of the human ureter. Urol Res. 1988;16(6):441-7. doi: 10.1007/BF00280026.
PubMed 2466358Hollingsworth JM, Canales BK, Rogers MA, Sukumar S, Yan P, Kuntz GM, Dahm P. Alpha blockers for treatment of ureteric stones: systematic review and meta-analysis. BMJ. 2016 Dec 1;355:i6112. doi: 10.1136/bmj.i6112.
PubMed 27908918Shokeir AA. Renal colic: new concepts related to pathophysiology, diagnosis and treatment. Curr Opin Urol. 2002 Jul;12(4):263-9. doi: 10.1097/00042307-200207000-00001.
PubMed 12072644
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Use of Alpha Blocker Versus Alpha Blocker and Antihistaminic in Management of Acute Renal Colic Prevent Pain Recurrence and Increase Expulsion Rate of Ureteric Stone ≤ 1cm
- ClinicalTrials.gov ID
- NCT05150899
- Acronym / sponsor ID
- antihistaminic in renal colic
- Conditions
- Renal Colic, Ureter Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (estimated)
- Primary completion
- 25 Nov 2022 (estimated)
- Study completion
- 25 Nov 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
Urolithiasis is one of the most common urological diseases. The risk of stone disease ranges between 5% and 12% worldwide. Ureteric stones account for ≈20% of all urinary tract stones and >70% of the ureteric stones are located in the lower third of the ureter, i.e., distal ureteric stones (DUS). The colicky-type pain in the ureter, an increase in proximal peristalsis through activation of intrinsic ureteral pacemakers may contribute to the perception of pain. Muscle spasm increased proximal peristalsis, local inflammation, irritation, and oedema at the site of obstruction may contribute to the development of pain through chemoreceptor activation and stretching of submucosal free nerve endings. α-adrenergic blockers, anti-inflammatory drugs, antihistaminic and calcium channel blockers, which have a relaxant effect on the ureteric smooth musculature. The presence of histamine receptors in the ureter have been presented in various studies. The histamine-1 (H1) receptors have been shown to have a wide distribution Histamine, which is secreted from the mast cells, causes strong peristaltic contractions in the ureter. alpha adrenoreceptor antagonists (i.e., tamsulosin) have been employed in the treatment of ureteric colic due to smooth muscle relaxation so their potential ability to increase stone passage, reduce pain medication use and reduce urologic interventions. According to the currently accepted view, renal colic management starts with NSAI drugs also NSAI has role in decrease inflammation and oedema and increase expulsion rate . in this study we will compare the use of alpha blocker versus alpha blocker and antihistaminic in management of acute renal colic prevent pain recurrence and increase expulsion rate of ureteric stone ≤ 1cm, with analgesic use in case of acute stage.
Detailed description
All the patients will be included within inclusion criteria After providing written informed consent, these patients were randomly divided into 2 groups by use of a computer-generated random number table.
- history taken about patient pain onset, duration and type with scoring the pain by World Health Organization numerical pain score of 0-10.
- Ultrasonography done to determine if kidney obstructed and grade of obstruction at the day 1 day 15 and day 30.
- group A receive Tamsulosin 0.4mg in combination of NSAI drug if patient present with colic, if not in renal colic at bed time Tamsulosin 0.4mg with analgesic on demand, group B receive pheniramine maleate 50mg injection every 12hr for 24 hr in combination of Tamsulosin 0.4mg and NSAI drug then fexofenadine 180 mg in combination of Tamsulosin 0.4mg and NSAI drug on demand if patient present with colic. if not in renal colic at bed time fexofenadine 180 mg in combination of Tamsulosin with NSAI on demand.
- In case of patient presented by acute renal colic the time of administration of treatment recorded and the time of relief pain recorded.
- CT scan done to ensure urolithiases if no CT done at the first day and after 30 days.
- Full labs done especially serum creatinine and serum uric acid.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.4mg | – | Drug: Tamsulosin Hcl 0.4Mg Capgroup A receive Tamsulosin 0.4mg in combination of NSAI drug if patient present with colic, if not in renal colic at bed time Tamsulosin 0.4mg with analgesic on demand. |
| fexofenadine 180 mg in combination of Tamsulosin 0.4mg | – | Drug: Tamsulosin Hcl 0.4Mg Cap, Drug: fexofenadine 180 mg Oral tabletgroup B receive pheniramine maleate 50mg injection every 12hr for 24 hr in combination of Tamsulosin 0.4mg and NSAI drug then fexofenadine 180 mg in combination of Tamsulosin 0.4mg and NSAI drug on demand if patient present with colic. if not in renal colic at bed time fexofenadine 180 mg in combination of Tamsulosin with NSAI on demand. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All cases that fulfil the selection criteria that will be followed up in the department of Assiut university hospital (non-probability sample size) with Confidence Level 90 %, Population Size 10000, Margin of Error 8 % with expected size of 100 patients enrolled in the study. these patients were randomly divided into 2 groups 50 in each group.
Key inclusion criteria (3 listed)
- Age from 14 to 70 years old.
- Patient with ureteric stone 5-10 MM.
- Patient with acute renal colic presented to emergency with obstructed kidney with urgent MSCT show stone ureter 5-10 MM and patient come without colic with CT showing lower third stone of the same measurement.
Key exclusion criteria (14 listed)
- Age less than 14 or more than 70.
- Chronically diseased patient cardiac that contraindicated to take PD5I or tamsulosin.
- Only functioning kidney.
- CKD Patient.
- Bilateral ureteric stone.
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 |
|---|---|---|
| Tamsulosin Hcl 0.4Mg CapAlso: tamsulealpha blocker | Drug | Tamsulosin 0.4mg, fexofenadine 180 mg in combination of Tamsulosin 0.4mg |
| fexofenadine 180 mg Oral tabletAlso: telefastantihistaminic | Drug | fexofenadine 180 mg in combination of Tamsulosin 0.4mg |
Primary outcome
Success rate of each treatment in case of patient presented with acute renal colic
Time frame: 3 weeks
(% of patients show relief of the pain).
Duration of relieve of the symptoms
Time frame: in 24 hours
relieve of renal colic
Rate of recurrence of pain and if need analgesic
Time frame: 3 weeks
how many times pain come again
Numbers of patients showing expulsion of stone
Time frame: 3 weeks
how many people stone expulsed during treatment
Number of patients underwent URS and duration taken from start of treatment
Time frame: 3 weeks
patient with persistent pain
Rate of complication from treatment
Time frame: 3 weeks
any side effect from treatment
Rate of hospital admission and number of admissions.
Time frame: 3 weeks
due to persistent pain
Rate of drop out from the study due to complication or noncompliance.
Time frame: 3 weeks
patient exit from study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Results publication: PubMed 22266271Bader MJ, Eisner B, Porpiglia F, Preminger GM, Tiselius HG. Contemporary management of ureteral stones. Eur Urol. 2012 Apr;61(4):764-72. doi: 10.1016/j.eururo.2012.01.009. Epub 2012 Jan 14.
- Results publication: PubMed 11756098Coll DM, Varanelli MJ, Smith RC. Relationship of spontaneous passage of ureteral calculi to stone size and location as revealed by unenhanced helical CT. AJR Am J Roentgenol. 2002 Jan;178(1):101-3. doi: 10.2214/ajr.178.1.1780101.
- Results publication: PubMed 17011944Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT, Hollenbeck BK. Medical therapy to facilitate urinary stone passage: a meta-analysis. Lancet. 2006 Sep 30;368(9542):1171-9. doi: 10.1016/S0140-6736(06)69474-9.
- Results publication: PubMed 23018163Giuliano F, Uckert S, Maggi M, Birder L, Kissel J, Viktrup L. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):506-16. doi: 10.1016/j.eururo.2012.09.006. Epub 2012 Sep 11.
- Results publication: PubMed 17102958Gratzke C, Uckert S, Kedia G, Reich O, Schlenker B, Seitz M, Becker AJ, Stief CG. In vitro effects of PDE5 inhibitors sildenafil, vardenafil and tadalafil on isolated human ureteral smooth muscle: a basic research approach. Urol Res. 2007 Feb;35(1):49-54. doi: 10.1007/s00240-006-0073-1. Epub 2006 Nov 11.
- Results publication: PubMed 25530364Kumar S, Jayant K, Agrawal MM, Singh SK, Agrawal S, Parmar KM. Role of tamsulosin, tadalafil, and silodosin as the medical expulsive therapy in lower ureteric stone: a randomized trial (a pilot study). Urology. 2015 Jan;85(1):59-63. doi: 10.1016/j.urology.2014.09.022.
- Results publication: PubMed 2466358Ugaily-Thulesius L, Thulesius O. The effects of urine on mast cells and smooth muscle of the human ureter. Urol Res. 1988;16(6):441-7. doi: 10.1007/BF00280026.
- Results publication: PubMed 27908918Hollingsworth JM, Canales BK, Rogers MA, Sukumar S, Yan P, Kuntz GM, Dahm P. Alpha blockers for treatment of ureteric stones: systematic review and meta-analysis. BMJ. 2016 Dec 1;355:i6112. doi: 10.1136/bmj.i6112.
- Results publication: PubMed 12072644Shokeir AA. Renal colic: new concepts related to pathophysiology, diagnosis and treatment. Curr Opin Urol. 2002 Jul;12(4):263-9. doi: 10.1097/00042307-200207000-00001.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Not yet recruiting
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
Recruiting
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Renal Colic, Acupuncture, Ear
Active, not recruiting
Sterile Water Injection vs Morphine for Renal Colic
Renal Colic, Urolithiasis
Not yet recruitingPhase 4
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
Renal Colic
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.
adel kurkar, MD principal investigator
Assiut University
mostafa kamel, demonstrator principal investigator
Assiut University
ahmed eltaher, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Colic and Ureter Stone, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact adel kurkar, MD (01098197880, adel.abdelmouteleb@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of each treatment in case of patient presented with acute renal colic (time frame: 3 weeks). The study lists 8 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 NCT05150899, which also lists 9 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 9 Dec 2021.