Uremic PruritusEarly Phase 1NCT04650750
The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
A Early Phase 1 study testing Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin in people with Uremic Pruritus, run by Chang Gung Memorial Hospital.
Trial summary
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 3 episodes of itch during 2 weeks or less, the itch occurring several times a day, lasting for more than 5 min and being bothersome
- An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1)
- People with clear consciousness, without cognitive impairment
- Those who can cooperate to fill in relevant questionnaires
- Willing to sign consent forms
- Blood test indicators: (1) Intact parathyroid hormone (iPTH) <600 pg/ml (2) Kt/V >1.2 (3) Serum phosphate <6 mg/dl
- Refractory uremic pruritus; The patient failed to respond to following treatments (1) avoiding food containing high amounts of phosphate (2) haemodialysis with a dialysate containing 3.0 or 2.5 mEq/l of calcium (3) changing the dialyser or increasing blood flow
Who cannot join
- Be younger than 20 years old.
- People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases.
- Patients with abnormal liver and kidney function.
- People suffering from cognitive dysfunction caused by neurological diseases or mental diseases.
- People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test.
- Those who are undergoing other trials.
- Those who are pregnant or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine.
Read the detailed description
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine. "Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
The purpose of this study is to evaluate the treatment effect of Xiao-Feng-San and Shian Fang Hwa Ming Yiin on uremic pruritus among hemodialysis patients in this randomized, double-blind, placebo-controlled study design.
- Conditions
- Uremic Pruritus
- Being tested
- Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin, Placebo
- Keywords
- Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiao-Feng-San+Shian-Fang-Hwa-Ming-YiinDrug
"Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
PlaceboDrug
Similar placebo 4g twice a day for two months
| Study group | Role | What they receive |
|---|---|---|
| Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin | Experimental | Xiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months Receives: Drug: Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin |
| Placebo | Placebo comparator | Similar placebo 4g twice a day for two months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale(VAS)
Measuring itch intensity
Measured: on starting day (day 0)
Visual Analogue Scale(VAS)
Measuring itch intensity
Measured: on day 28
Visual Analogue Scale(VAS)
Measuring itch intensity
Measured: on day 56
Visual Analogue Scale(VAS)
Measuring itch intensity
Measured: on day 84
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Measured: on starting day (day 0)
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Measured: on day 28
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Measured: on day 56
5-D itch scale
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Measured: on day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650750
- Sponsor's protocol ID
- CMRPG1J0131
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mathur VS, Lindberg J, Germain M, Block G, Tumlin J, Smith M, Grewal M, McGuire D; ITCH National Registry Investigators. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Aug;5(8):1410-9. doi: 10.2215/CJN.00100110. Epub 2010 Jun 17.
PubMed 20558560Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, Hasegawa T, Kleophas W, Bieber BA, Tentori F, Robinson BM, Pisoni RL. International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2000-2007. doi: 10.2215/CJN.03280317. Epub 2017 Sep 18.
PubMed 28923831Kuypers DR. Skin problems in chronic kidney disease. Nat Clin Pract Nephrol. 2009 Mar;5(3):157-70. doi: 10.1038/ncpneph1040. Epub 2009 Feb 3.
PubMed 19190625Szepietowski JC, Morita A, Tsuji T. Ultraviolet B induces mast cell apoptosis: a hypothetical mechanism of ultraviolet B treatment for uraemic pruritus. Med Hypotheses. 2002 Feb;58(2):167-70. doi: 10.1054/mehy.2001.1505.
PubMed 11812197Kim KH, Lee MS, Choi SM. Acupuncture for treating uremic pruritus in patients with end-stage renal disease: a systematic review. J Pain Symptom Manage. 2010 Jul;40(1):117-25. doi: 10.1016/j.jpainsymman.2009.11.325.
PubMed 21796811Okada K, Matsumoto K. Effect of skin care with an emollient containing a high water content on mild uremic pruritus. Ther Apher Dial. 2004 Oct;8(5):419-22. doi: 10.1111/j.1526-0968.2004.00175.x.
PubMed 15663539Young TA, Patel TS, Camacho F, Clark A, Freedman BI, Kaur M, Fountain J, Williams LL, Yosipovitch G, Fleischer AB Jr. A pramoxine-based anti-itch lotion is more effective than a control lotion for the treatment of uremic pruritus in adult hemodialysis patients. J Dermatolog Treat. 2009;20(2):76-81. doi: 10.1080/09546630802441218.
PubMed 18821119Tarng DC, Cho YL, Liu HN, Huang TP. Hemodialysis-related pruritus: a double-blind, placebo-controlled, crossover study of capsaicin 0.025% cream. Nephron. 1996;72(4):617-22. doi: 10.1159/000188949.
PubMed 8730431Russo GE, Spaziani M, Guidotti C, Scarpellini MG, Leri O, Bonini S, Crisciotti C, Carmenini G. [Pruritus in chronic uremic patients in periodic hemodialysis. Treatment with terfenadine (an antagonist of histamine H1 receptors)]. Minerva Urol Nefrol. 1986 Oct-Dec;38(4):443-7. No abstract available. Italian.
PubMed 2884733Rayner H, Baharani J, Smith S, Suresh V, Dasgupta I. Uraemic pruritus: relief of itching by gabapentin and pregabalin. Nephron Clin Pract. 2012;122(3-4):75-9. doi: 10.1159/000349943. Epub 2013 Mar 28.
PubMed 23548570Simonsen E, Komenda P, Lerner B, Askin N, Bohm C, Shaw J, Tangri N, Rigatto C. Treatment of Uremic Pruritus: A Systematic Review. Am J Kidney Dis. 2017 Nov;70(5):638-655. doi: 10.1053/j.ajkd.2017.05.018. Epub 2017 Jul 15.
PubMed 28720208Cheng HM, Chiang LC, Jan YM, Chen GW, Li TC. The efficacy and safety of a Chinese herbal product (Xiao-Feng-San) for the treatment of refractory atopic dermatitis: a randomized, double-blind, placebo-controlled trial. Int Arch Allergy Immunol. 2011;155(2):141-8. doi: 10.1159/000318861. Epub 2010 Dec 22.
PubMed 21196758Chen HY, Lin YH, Chen YC. Identifying Chinese herbal medicine network for treating acne: Implications from a nationwide database. J Ethnopharmacol. 2016 Feb 17;179:1-8. doi: 10.1016/j.jep.2015.12.032. Epub 2015 Dec 22.
PubMed 26721214
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Effect of Chinese Medicine Formula on Uremic Pruritus
- ClinicalTrials.gov ID
- NCT04650750
- Acronym / sponsor ID
- CMRPG1J0131
- Conditions
- Uremic Pruritus
- Keywords
- Uremic pruritus; Hemodialysis; Chinese medicine; Xiao-Feng-San; Shian Fang Hwa Ming Yiin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Dec 2020 (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 prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine.
Detailed description
The prevalence of hemodialysis patients is increasing in recent years. And the uremic pruritus is a common and bothersome symptom among the patients. Current therapies for uremic pruritus, including dialysis modification, topical treatment such as emollients and topical analgesic agent, phototherapy, acupuncture, and gabapentin. However, the efficacy of these treatments remains poorly defined.
In our experiment, the investigators tried to find an effective way to control uremic pruritus through Chinese traditional medicine. "Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect.
The purpose of this study is to evaluate the treatment effect of Xiao-Feng-San and Shian Fang Hwa Ming Yiin on uremic pruritus among hemodialysis patients in this randomized, double-blind, placebo-controlled study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin | Experimental | Drug: Xiao-Feng-San+Shian-Fang-Hwa-Ming-YiinXiao-Feng-San 2g+ Shian Fang Hwa Ming Yiin 2g; twice a day for two months |
| Placebo | Placebo comparator | Drug: PlaceboSimilar placebo 4g twice a day for two months |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 3 episodes of itch during 2 weeks or less, the itch occurring several times a day, lasting for more than 5 min and being bothersome
- An intermittent itch over a period of 6 months or more, with a clinical appearance, but with a lower frequency than in (1)
- People with clear consciousness, without cognitive impairment
- Those who can cooperate to fill in relevant questionnaires
- Willing to sign consent forms
Key exclusion criteria (7 listed)
- Be younger than 20 years old.
- People suffering from diagnosed skin diseases (scabies, drug allergy, atopic dermatitis), severe infections, liver failure, blood diseases or biliary diseases.
- Patients with abnormal liver and kidney function.
- People suffering from cognitive dysfunction caused by neurological diseases or mental diseases.
- People with severe visual impairment, hearing impairment, and physical impairment that affect the scale test.
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 |
|---|---|---|
| Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin"Xiao-Feng-San" is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of "Xiao-Feng-San" has immunomodulatory activity. "Shian Fang Hwa Ming Yiin" is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of "Shian Fang Hwa Ming Yiin" has anti-inflammation and anti-microbial effect. | Drug | Xiao-Feng-San; Shian-Fang-Hwa-Ming-Yiin |
| PlaceboSimilar placebo 4g twice a day for two months | Drug | Placebo |
Primary outcome
Visual Analogue Scale(VAS)
Time frame: on starting day (day 0)
Measuring itch intensity
Visual Analogue Scale(VAS)
Time frame: on day 28
Measuring itch intensity
Visual Analogue Scale(VAS)
Time frame: on day 56
Measuring itch intensity
Visual Analogue Scale(VAS)
Time frame: on day 84
Measuring itch intensity
5-D itch scale
Time frame: on starting day (day 0)
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
5-D itch scale
Time frame: on day 28
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
5-D itch scale
Time frame: on day 56
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
5-D itch scale
Time frame: on day 84
(1) duration of itchiness, (2) degree of itchiness, (3) direction of itchiness, (4) disability caused by itchiness, and (5) distribution of itchiness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 20558560Mathur VS, Lindberg J, Germain M, Block G, Tumlin J, Smith M, Grewal M, McGuire D; ITCH National Registry Investigators. A longitudinal study of uremic pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Aug;5(8):1410-9. doi: 10.2215/CJN.00100110. Epub 2010 Jun 17.
- Background: PubMed 28923831Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, Hasegawa T, Kleophas W, Bieber BA, Tentori F, Robinson BM, Pisoni RL. International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2000-2007. doi: 10.2215/CJN.03280317. Epub 2017 Sep 18.
- Background: PubMed 19190625Kuypers DR. Skin problems in chronic kidney disease. Nat Clin Pract Nephrol. 2009 Mar;5(3):157-70. doi: 10.1038/ncpneph1040. Epub 2009 Feb 3.
- Background: PubMed 11812197Szepietowski JC, Morita A, Tsuji T. Ultraviolet B induces mast cell apoptosis: a hypothetical mechanism of ultraviolet B treatment for uraemic pruritus. Med Hypotheses. 2002 Feb;58(2):167-70. doi: 10.1054/mehy.2001.1505.
- Background: PubMed 21796811Kim KH, Lee MS, Choi SM. Acupuncture for treating uremic pruritus in patients with end-stage renal disease: a systematic review. J Pain Symptom Manage. 2010 Jul;40(1):117-25. doi: 10.1016/j.jpainsymman.2009.11.325.
- Background: PubMed 15663539Okada K, Matsumoto K. Effect of skin care with an emollient containing a high water content on mild uremic pruritus. Ther Apher Dial. 2004 Oct;8(5):419-22. doi: 10.1111/j.1526-0968.2004.00175.x.
- Background: PubMed 18821119Young TA, Patel TS, Camacho F, Clark A, Freedman BI, Kaur M, Fountain J, Williams LL, Yosipovitch G, Fleischer AB Jr. A pramoxine-based anti-itch lotion is more effective than a control lotion for the treatment of uremic pruritus in adult hemodialysis patients. J Dermatolog Treat. 2009;20(2):76-81. doi: 10.1080/09546630802441218.
- Background: PubMed 8730431Tarng DC, Cho YL, Liu HN, Huang TP. Hemodialysis-related pruritus: a double-blind, placebo-controlled, crossover study of capsaicin 0.025% cream. Nephron. 1996;72(4):617-22. doi: 10.1159/000188949.
- Background: PubMed 2884733Russo GE, Spaziani M, Guidotti C, Scarpellini MG, Leri O, Bonini S, Crisciotti C, Carmenini G. [Pruritus in chronic uremic patients in periodic hemodialysis. Treatment with terfenadine (an antagonist of histamine H1 receptors)]. Minerva Urol Nefrol. 1986 Oct-Dec;38(4):443-7. No abstract available. Italian.
- Background: PubMed 23548570Rayner H, Baharani J, Smith S, Suresh V, Dasgupta I. Uraemic pruritus: relief of itching by gabapentin and pregabalin. Nephron Clin Pract. 2012;122(3-4):75-9. doi: 10.1159/000349943. Epub 2013 Mar 28.
- Background: PubMed 28720208Simonsen E, Komenda P, Lerner B, Askin N, Bohm C, Shaw J, Tangri N, Rigatto C. Treatment of Uremic Pruritus: A Systematic Review. Am J Kidney Dis. 2017 Nov;70(5):638-655. doi: 10.1053/j.ajkd.2017.05.018. Epub 2017 Jul 15.
- Background: PubMed 21196758Cheng HM, Chiang LC, Jan YM, Chen GW, Li TC. The efficacy and safety of a Chinese herbal product (Xiao-Feng-San) for the treatment of refractory atopic dermatitis: a randomized, double-blind, placebo-controlled trial. Int Arch Allergy Immunol. 2011;155(2):141-8. doi: 10.1159/000318861. Epub 2010 Dec 22.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin in people with Uremic Pruritus, run by Chang Gung Memorial Hospital.
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 7 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Jiun-Liang Chen, Ph.D (+88633196200 ext. 2611, a12015@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale(VAS) (time frame: on starting day (day 0)). 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 NCT04650750, which also lists 13 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 3 Dec 2020.