ConstipationPhase 4NCT03148002
Peritoneal Dialysis Pilot Study: Evaluating Polyethylene Glycol (PEG) for Constipation
A Phase 4 study testing Current Bowel Protocol (senna/lactulose) and PEG Bowel Protocol (PEG/lactulose) in people with Constipation and Peritoneal Dialysis Complication, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Constipation is a common condition, which occurs one in four Canadians. Maintaining regular bowel movements is imperative because constipation can affect the quality of PD dialysate flow and result in an unwanted effect on the dialysis adequacy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Constipation, Peritoneal Dialysis Complication
- What is being tested?
- Current Bowel Protocol (senna/lactulose) and PEG Bowel Protocol (PEG/lactulose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2017to 5 Jun 2018
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients in the peritoneal dialysis program in Nova Scotia who are currently taking laxatives.
Who cannot join
- Allergy or intolerance to any of the study laxatives (PEG, senna, lactulose); cognitive impairment or inability to document symptoms; known or suspected gastrointestinal obstruction or ileus; known or planned pregnancy; no laxative use in the last 3 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
About this study
Official title: An Evaluation of the Efficacy and Safety of a Polyethylene Glycol (PEG) Based Bowel Protocol for the Management of Constipation in Peritoneal Dialysis Patients: A Pilot Study
Constipation is a common condition, which occurs one in four Canadians. Maintaining regular bowel movements is imperative because constipation can affect the quality of PD dialysate flow and result in an unwanted effect on the dialysis adequacy.
There is limited data on how to best manage constipation in the peritoneal dialysis population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for prevention and treatment of constipation across Canada. Although some PD programs in Canada have already converted to PEG for management of constipation, more research in this population would help guide practice. For now, the current PD bowel regimen at the Nova Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant laxative, senna, along with an osmotic laxative, lactulose, for acute constipation.
Read more
The investigators will review all patients in the NSHA PD program who have regular or recent laxative use for participation in this study. Patients included in this study will be randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks.
The goal is to determine if the PEG Bowel Protocol is as effective and safe for the prevention of constipation as the Current Bowel Protocol used in the PD Program. The investigators will use bowel function diaries and patient surveys to determine efficacy and safety outcomes.
Read the detailed description
Constipation is a common condition, which impacts one in four Canadians Maintaining regular bowel movements is important in the peritoneal dialysis (PD) population because constipation can negatively impact the quality of dialysate flow and can result in impaired dialysis adequacy. Unfortunately, treating constipation is challenging in PD patients because of the diet and fluid restrictions required in this population, as well as the need for constipating calcium based phosphate binders.
Constipation treatment can be administered orally or rectally. Although patients often prefer oral therapy, there are occasions when rectal therapy is preferred (ie. rectal suppositories and enemas). Oral laxatives include bulk, osmotic, stimulant, and lubricants.
In the Nova Scotia (NS) PD Program, patients are counseled to maintain a type 3-4 stool on the Bristol Stool Chart (BSC). An ideal stool is a type 4, which appears like a sausage or snake and is smooth and soft in consistency. To maintain a type 3-4 stool, current therapy includes senna 8.6-17.2 g twice daily with the addition of lactulose 30-60 mL twice daily, as needed. Rescue therapy in the Current Bowel Protocol is lactulose 30-60 mL every hour until bowel movement.
There is limited evidence to guide the ideal bowel regimen in PD patients. Reasons to consider PEG therapy include the evidence promoting PEG in the general population with constipation, the positive outcomes found in a small population of PD patients (Mimidis 2005), as well as positive feedback from other provinces who currently recommend PEG in PD patients. The investigators postulate the PEG protocol would be as effective and safe as the Current Bowel Protocol, and thus will evaluate PEG in the PD population, the investigators will conduct a prospective, interventional, randomized, open label, pilot study.
All patients with recent laxative use will be approached for inclusion. Patients will be randomly assigned to the Current Bowel Protocol (senna/lactulose) or the PEG Bowel Protocol (PEG/lactulose) for 8 weeks.
The primary objective is to compare the efficacy of the PEG Bowel Protocol in preventing constipation to the Current Bowel Protocol. We will review the safety of the regimens by monitoring for adverse events from all laxatives and explore the impact of constipation in patients who experience PD treatment failure.
- Conditions
- Constipation, Peritoneal Dialysis Complication
- Being tested
- Current Bowel Protocol (senna/lactulose), PEG Bowel Protocol (PEG/lactulose)
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current Bowel Protocol (senna/lactulose)Drug
Also called Senna, Lactulose, Sennosides, DIN 02242814
Stimulant and Osmotic Laxatives.
PEG Bowel Protocol (PEG/lactulose)Drug
Also called PEG, Lax-A-Day, Pegalax, DIN: 02328232
Osmotic Laxatives.
| Study group | Role | What they receive |
|---|---|---|
| Current Bowel Protocol | Active comparator | Patients will receive the Current Bowel Protocol with senna. Lactulose will be used for rescue therapy. Receives: Drug: Current Bowel Protocol (senna/lactulose) |
| PEG Bowel Protocol | Active comparator | Patients will receive the Protocol with Polyethylene Glycol 3350. Lactulose will be used for rescue therapy. Receives: Drug: PEG Bowel Protocol (PEG/lactulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of constipation treatment success
Successful treatment of constipation will be defined based on a modified ROME criteria developed by Dipalma 2007: relief of constipation for more than 50% of the weeks in the study.
Measured: 8 weeks.
Secondary outcomes (4)
Number of patients with laxative related adverse effects.
Compare the occurrence of side effects during the study period.
Measured: 8 weeks.
Mean change from baseline on the PAC-SYM questionnaire
Measure of the impact of constipation disease severity. PAC-SYM = Patient Assessment of Constipation Symptoms (Frank 1999 and Bove 2012)
Measured: 8 weeks.
Mean change from baseline on the PAC-QOL questionnaire
Measure the impact of constipation on quality of life. PAC-QOL = Patient Assessment of Constipation Quality of Life (Marquis 2005 and Bove 2012)
Measured: 8 weeks
Incidence of peritoneal dialysis treatment failure requiring intervention
Interventions include antibiotics for peritonitis, catheter re-positioning.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start7 Jul 2017
- Primary completion1 Apr 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to received the Current Bowel Protocol or the PEG Bowel Protocol
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaclyn Y Tran, BScPharm, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148002
- Sponsor's protocol ID
- PDBowel2017
- Status last verified
- Aug 2024
- First submitted
- 14 Mar 2017
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mimidis K, Mourvati E, Kaliontzidou M, Papadopoulos V, Thodis E, Kartalis G, Vargemezis V. Efficacy of polyethylene glycol in constipated CAPD patients. Perit Dial Int. 2005 Nov-Dec;25(6):601-3. No abstract available.
PubMed 16411529Setyapranata S, Holt SG. The Gut in Older Patients on Peritoneal Dialysis. Perit Dial Int. 2015 Nov;35(6):650-4. doi: 10.3747/pdi.2014.00341.
PubMed 26702007Pare P, Ferrazzi S, Thompson WG, Irvine EJ, Rance L. An epidemiological survey of constipation in canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol. 2001 Nov;96(11):3130-7. doi: 10.1111/j.1572-0241.2001.05259.x.
PubMed 11721760Sutton D, Dumbleton S, Allaway C. Can increased dietary fibre reduce laxative requirement in peritoneal dialysis patients? J Ren Care. 2007 Oct-Dec;33(4):174-8. doi: 10.1111/j.1755-6686.2007.tb00068.x.
PubMed 18298035Sutton D, Ovington S, Engel B. A multi-centre, randomised trial to assess whether increased dietary fibre intake (using a fibre supplement or high-fibre foods) produces healthy bowel performance and reduces laxative requirement in free living patients on peritoneal dialysis. J Ren Care. 2014 Sep;40(3):157-63. doi: 10.1111/jorc.12056. Epub 2014 Mar 20.
PubMed 24650128Dessau RB, Olsen OB, Frifelt JJ, Skott H. Influence of psyllium seed husk on azotemia, electrolytes, and bowel regulation in patients on CAPD. Perit Dial Int. 1989;9(4):351. No abstract available.
PubMed 2488394Pare P. The approach to diagnosis and treatment of chronic constipation: suggestions for a general practitioner. Can J Gastroenterol. 2011 Oct;25 Suppl B(Suppl B):36B-40B. doi: 10.1155/2011/368189.
PubMed 22114756Liu LW. Chronic constipation: current treatment options. Can J Gastroenterol. 2011 Oct;25 Suppl B(Suppl B):22B-28B.
PubMed 22114754Schuster BG, Kosar L, Kamrul R. Constipation in older adults: stepwise approach to keep things moving. Can Fam Physician. 2015 Feb;61(2):152-8. No abstract available.
PubMed 25676646Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005 Apr;100(4):936-71. doi: 10.1111/j.1572-0241.2005.40925.x.
PubMed 15784043Hsieh C. Treatment of constipation in older adults. Am Fam Physician. 2005 Dec 1;72(11):2277-84.
PubMed 16342852Di Palma JA, Smith JR, Cleveland Mv. Overnight efficacy of polyethylene glycol laxative. Am J Gastroenterol. 2002 Jul;97(7):1776-9. doi: 10.1111/j.1572-0241.2002.05840.x.
PubMed 12135034Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, Alix E, Salmeron M, Guillemot F, Chaussade S, Menard AM, Moreau J, Naudin G, Barthet M. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Gut. 1999 Feb;44(2):226-30. doi: 10.1136/gut.44.2.226.
PubMed 9895382Lee-Robichaud H, Thomas K, Morgan J, Nelson RL. Lactulose versus Polyethylene Glycol for Chronic Constipation. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD007570. doi: 10.1002/14651858.CD007570.pub2.
PubMed 20614462Christie AH, Culbert P, Guest JF. Economic impact of low dose polyethylene glycol 3350 plus electrolytes compared with lactulose in the management of idiopathic constipation in the UK. Pharmacoeconomics. 2002;20(1):49-60. doi: 10.2165/00019053-200220010-00005.
PubMed 11817992
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy and Safety of a Polyethylene Glycol (PEG) Based Bowel Protocol for the Management of Constipation in Peritoneal Dialysis Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03148002
- Acronym / sponsor ID
- PDBowel2017
- Conditions
- Constipation, Peritoneal Dialysis Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 10 May 2017 (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.
Constipation is a common condition, which occurs one in four Canadians. Maintaining regular bowel movements is imperative because constipation can affect the quality of PD dialysate flow and result in an unwanted effect on the dialysis adequacy.
There is limited data on how to best manage constipation in the peritoneal dialysis population. Polyethylene glycol (PEG) is an osmotic laxative that is becoming popular for prevention and treatment of constipation across Canada. Although some PD programs in Canada have already converted to PEG for management of constipation, more research in this population would help guide practice. For now, the current PD bowel regimen at the Nova Scotia Health Authority (NSHA) includes daily preventative therapy using a stimulant laxative, senna, along with an osmotic laxative, lactulose, for acute constipation.
The investigators will review all patients in the NSHA PD program who have regular or recent laxative use for participation in this study. Patients included in this study will be randomly assigned to the Current Bowel Protocol or the PEG Bowel Protocol for 8 weeks.
The goal is to determine if the PEG Bowel Protocol is as effective and safe for the prevention of constipation as the Current Bowel Protocol used in the PD Program. The investigators will use bowel function diaries and patient surveys to determine efficacy and safety outcomes.
Detailed description
Constipation is a common condition, which impacts one in four Canadians Maintaining regular bowel movements is important in the peritoneal dialysis (PD) population because constipation can negatively impact the quality of dialysate flow and can result in impaired dialysis adequacy. Unfortunately, treating constipation is challenging in PD patients because of the diet and fluid restrictions required in this population, as well as the need for constipating calcium based phosphate binders.
Constipation treatment can be administered orally or rectally. Although patients often prefer oral therapy, there are occasions when rectal therapy is preferred (ie. rectal suppositories and enemas). Oral laxatives include bulk, osmotic, stimulant, and lubricants.
In the Nova Scotia (NS) PD Program, patients are counseled to maintain a type 3-4 stool on the Bristol Stool Chart (BSC). An ideal stool is a type 4, which appears like a sausage or snake and is smooth and soft in consistency. To maintain a type 3-4 stool, current therapy includes senna 8.6-17.2 g twice daily with the addition of lactulose 30-60 mL twice daily, as needed. Rescue therapy in the Current Bowel Protocol is lactulose 30-60 mL every hour until bowel movement.
There is limited evidence to guide the ideal bowel regimen in PD patients. Reasons to consider PEG therapy include the evidence promoting PEG in the general population with constipation, the positive outcomes found in a small population of PD patients (Mimidis 2005), as well as positive feedback from other provinces who currently recommend PEG in PD patients. The investigators postulate the PEG protocol would be as effective and safe as the Current Bowel Protocol, and thus will evaluate PEG in the PD population, the investigators will conduct a prospective, interventional, randomized, open label, pilot study.
All patients with recent laxative use will be approached for inclusion. Patients will be randomly assigned to the Current Bowel Protocol (senna/lactulose) or the PEG Bowel Protocol (PEG/lactulose) for 8 weeks.
The primary objective is to compare the efficacy of the PEG Bowel Protocol in preventing constipation to the Current Bowel Protocol. We will review the safety of the regimens by monitoring for adverse events from all laxatives and explore the impact of constipation in patients who experience PD treatment failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to received the Current Bowel Protocol or the PEG Bowel Protocol
| Arm | Type | Receives |
|---|---|---|
| Current Bowel Protocol | Active comparator | Drug: Current Bowel Protocol (senna/lactulose)Patients will receive the Current Bowel Protocol with senna. Lactulose will be used for rescue therapy. |
| PEG Bowel Protocol | Active comparator | Drug: PEG Bowel Protocol (PEG/lactulose)Patients will receive the Protocol with Polyethylene Glycol 3350. Lactulose will be used for rescue therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients in the peritoneal dialysis program in Nova Scotia who are currently taking laxatives.
Key exclusion criteria (1 listed)
- Allergy or intolerance to any of the study laxatives (PEG, senna, lactulose); cognitive impairment or inability to document symptoms; known or suspected gastrointestinal obstruction or ileus; known or planned pregnancy; no laxative use in the last 3 months.
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 |
|---|---|---|
| Current Bowel Protocol (senna/lactulose)Also: Senna, Lactulose, Sennosides, DIN 02242814Stimulant and Osmotic Laxatives. | Drug | Current Bowel Protocol |
| PEG Bowel Protocol (PEG/lactulose)Also: PEG, Lax-A-Day, Pegalax, DIN: 02328232Osmotic Laxatives. | Drug | PEG Bowel Protocol |
Primary outcome
Rate of constipation treatment success
Time frame: 8 weeks.
Successful treatment of constipation will be defined based on a modified ROME criteria developed by Dipalma 2007: relief of constipation for more than 50% of the weeks in the study.
4 secondary outcomes
Number of patients with laxative related adverse effects.
Time frame: 8 weeks.
Mean change from baseline on the PAC-SYM questionnaire
Time frame: 8 weeks.
Mean change from baseline on the PAC-QOL questionnaire
Time frame: 8 weeks
Incidence of peritoneal dialysis treatment failure requiring intervention
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 16411529Mimidis K, Mourvati E, Kaliontzidou M, Papadopoulos V, Thodis E, Kartalis G, Vargemezis V. Efficacy of polyethylene glycol in constipated CAPD patients. Perit Dial Int. 2005 Nov-Dec;25(6):601-3. No abstract available.
- Background: PubMed 26702007Setyapranata S, Holt SG. The Gut in Older Patients on Peritoneal Dialysis. Perit Dial Int. 2015 Nov;35(6):650-4. doi: 10.3747/pdi.2014.00341.
- Background: PubMed 11721760Pare P, Ferrazzi S, Thompson WG, Irvine EJ, Rance L. An epidemiological survey of constipation in canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol. 2001 Nov;96(11):3130-7. doi: 10.1111/j.1572-0241.2001.05259.x.
- Background: PubMed 18298035Sutton D, Dumbleton S, Allaway C. Can increased dietary fibre reduce laxative requirement in peritoneal dialysis patients? J Ren Care. 2007 Oct-Dec;33(4):174-8. doi: 10.1111/j.1755-6686.2007.tb00068.x.
- Background: PubMed 24650128Sutton D, Ovington S, Engel B. A multi-centre, randomised trial to assess whether increased dietary fibre intake (using a fibre supplement or high-fibre foods) produces healthy bowel performance and reduces laxative requirement in free living patients on peritoneal dialysis. J Ren Care. 2014 Sep;40(3):157-63. doi: 10.1111/jorc.12056. Epub 2014 Mar 20.
- Background: PubMed 2488394Dessau RB, Olsen OB, Frifelt JJ, Skott H. Influence of psyllium seed husk on azotemia, electrolytes, and bowel regulation in patients on CAPD. Perit Dial Int. 1989;9(4):351. No abstract available.
- Background: PubMed 22114756Pare P. The approach to diagnosis and treatment of chronic constipation: suggestions for a general practitioner. Can J Gastroenterol. 2011 Oct;25 Suppl B(Suppl B):36B-40B. doi: 10.1155/2011/368189.
- Background: PubMed 22114754Liu LW. Chronic constipation: current treatment options. Can J Gastroenterol. 2011 Oct;25 Suppl B(Suppl B):22B-28B.
- Background: PubMed 25676646Schuster BG, Kosar L, Kamrul R. Constipation in older adults: stepwise approach to keep things moving. Can Fam Physician. 2015 Feb;61(2):152-8. No abstract available.
- Background: PubMed 15784043Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005 Apr;100(4):936-71. doi: 10.1111/j.1572-0241.2005.40925.x.
- Background: PubMed 16342852Hsieh C. Treatment of constipation in older adults. Am Fam Physician. 2005 Dec 1;72(11):2277-84.
- Background: PubMed 12135034Di Palma JA, Smith JR, Cleveland Mv. Overnight efficacy of polyethylene glycol laxative. Am J Gastroenterol. 2002 Jul;97(7):1776-9. doi: 10.1111/j.1572-0241.2002.05840.x.
- 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.
Jaclyn Y Tran, BScPharm principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Current Bowel Protocol (senna/lactulose) and PEG Bowel Protocol (PEG/lactulose) in people with Constipation and Peritoneal Dialysis Complication, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of constipation treatment success (time frame: 8 weeks.). 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 NCT03148002, which also lists 23 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 Aug 2024.