Inflammatory Bowel DiseasesPhase 4NCT04304950

Chronotherapy in Inflammatory Bowel Disease

A Phase 4 study testing Evening Group and Morning Group in people with Inflammatory Bowel Diseases, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Inflammatory Bowel Diseases
What is being tested?: Evening Group and Morning Group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 25 Apr 2016to Apr 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Above the ages of 18
Diagnosis of Crohn's Disease or Ulcerative Colitis
Currently taking azathioprine or 6-mercaptopurine
Willing to sign study consent form

Who cannot join

Vulnerable population (pregnant, prisoner, non-English speaking or cognitively impaired)
Breastfeeding subject
Have a history of complications related to immunomodulatory therapy
Participating in other research studies involving research interventions
Treated with dual corticosteroid and immunomodulatory therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel Disease (IBD) medication and disease outcomes when taken in the morning or in the evening. The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team believes that there may be a benefit to taking the medication at a certain time of day. To test this theory the study asks participants who are already taking either azathioprine or 6-mercaptopurine for IBD to take the medication consistently at either the morning or in the evening based on when they currently take their medication. Participation is up to 10 weeks +/- 3 days. There will be 2 study visits where the participant will be asked to fill in questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general health information followed by a blood draw.

Read the detailed description

The objective of this study is to determine whether the timing of drug administration to treat inflammatory bowel disease (IBD) has an effect on patient outcomes. Primary objective: Determine whether there is a difference in outcomes seen when patients are assigned to take their prescribed immunomodulator (IM) - either Azathioprine or 6-Mercaptopurine - at either a morning delivery time or evening delivery time.

The Investigator hypothesize that administration time of immunomodulators (IMs) during the day can affect the clinical outcomes in IBD patients.

Specific Aims Include:

Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect the subclinical markers of inflammation related to disease.
Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect endoscopic outcomes.
Determine whether morning vs. evening dosing of IMs affect their biochemical side effects, as is routinely monitored as part of the patients' clinical care.
Determine if outcomes correlate with patients' chronotype, as determined by standard questionnaires (the Munich Chronotype Questionnaire).

Description of Procedures: After signing the informed consent form, subjects will be asked to answer the Inflammatory Bowel Disease Questionnaire (IBDQ), the Munich Chronotype Questionnaire (MCTQ), the Harvey Bradshaw questionnaire, and a demographics survey. All six of these questionnaires are included with this IRB. Next, patients will be assigned a time (morning or evening) to self administer their prescribed medication for 10 weeks. Patients who currently take their medication in the morning will be asked to switch to an evening delivery and patients who currently take their medication at night will be asked to switch to a morning delivery. The group assigned to morning delivery time will be told to take their medication between 6am and 11am. The group assigned to evening delivery time will be told to take their medication between 6pm and 11pm. Lastly, patients will be asked to give a blood sample to test for complete blood count (CBC), comprehensive metabolic panel (CMP), C-reactive protein (CRP), methylmercaptopurine (6-MMP), and thioguanine nucleotides (6-TG). Plasma and serum isolated from the blood sample will be temporarily stored to measure inflammatory cytokines after every 20 subjects complete the study.

Within a 6-10 week window, as part of their clinical care, subjects will come in to assess their clinical status while undergoing biochemical monitoring every 2-4 weeks. Data from their endoscopic examination, if done, will also be collected.

After 10 weeks, the subjects will be asked to complete the IBDQ and Harvey Bradshaw questionnaire. In addition, a blood sample will be obtained to measure the same metabolite levels and other biochemical indications of disease as stated above. Again, plasma and serum will be isolated from the blood sample and stored.

Conditions: Inflammatory Bowel Diseases
Being tested: Evening Group, Morning Group
Medical subject headings: Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Evening GroupDrug
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.
Morning GroupDrug
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.

Study groups in NCT04304950
Study group	Role	What they receive
Morning	Experimental	Participants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the evening were assigned to the morning group. Instead of taking their medication at their usual PM time, they were instructed to take their medications in the morning for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol. Receives: Drug: Morning Group
Evening	Experimental	Participants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the morning were assigned to the evening group. Instead of taking their medication at their usual AM time, they were instructed to take their medications in the evening for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol. Receives: Drug: Evening Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Thioguanine Levels in Blood (Morning Versus Evening Dosing)
This is to examine if the intervention results in a greater level of thioguanine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.
Measured: 10 weeks post baseline visit.
Harvey Bradshaw Activity Index
Harvey Bradshaw Activity Index has 5 questions. The final score is totaled and will fall into the following categories, which are used to define the severity of the disease: >16 severe diseases, 8-16 moderate disease, 5-7 mild disease, <5 remission. Scores range from 0 ( lowest possible score) to 17.
Measured: 10 weeks post baseline visit.
Short Inflammatory Bowel Disease Questionnaire
Quality of Life Measure Score:1-7 (The higher the number the greater the quality of life)
Measured: 10 weeks post baseline visit.
6-Methylmercaptopurine Levels in Blood
This is to examine if the intervention results in a lower level of 6-Methylmercaptopurine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.
Measured: 10 weeks post baseline visit.

Secondary outcomes (1)

Munich Chronotype Questionnaire ( MCTQ)
This questionnaire is used to collect primary sleep times, such as bed- and rise-times, including the time a person is fully awake, sleep latency and inertia, in addition to other time points. The MCTQ uses the midpoint of sleep between sleep onset and offset to assess chronotype. Chronotype is your body's natural time to be awake or asleep at certain times. Total scores can range from 16 to 86, with the lowest values representing extreme-late chronotype. For this study corrected midpoint of sleep (MSFc) was calculated. This information is combined to determine the mean time of day at which respondents were more likely to feel most alert. The numbers provided in the outcome measure data table represent time (hour and minute). The hour has been converted to military time and the minutes were converted to decimals.
Measured: 10 weeks post baseline visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 2016Apr 2023

First posted12 Mar 2020
Study start25 Apr 2016
Primary completionDec 2021
Study completionApr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Inflammatory Bowel DiseasesStudies 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: Participants will be randomized to one of two groups: Evening Time or Morning Time. Participants are used as their own control. The evening time group will take their medication in the evening and the morning time group will take the medication in the morning.
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04304950
Sponsor's protocol ID: 16040505
Status last verified: Jun 2023
First submitted: 6 Aug 2019
Last updated: 27 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ardizzone S, Bianchi Porro G. Biologic therapy for inflammatory bowel disease. Drugs. 2005;65(16):2253-86. doi: 10.2165/00003495-200565160-00002.
PubMed 16266194
Belaiche J, Desager JP, Horsmans Y, Louis E. Therapeutic drug monitoring of azathioprine and 6-mercaptopurine metabolites in Crohn disease. Scand J Gastroenterol. 2001 Jan;36(1):71-6. doi: 10.1080/00365520150218084.
PubMed 11218242
Bradford K, Shih DQ. Optimizing 6-mercaptopurine and azathioprine therapy in the management of inflammatory bowel disease. World J Gastroenterol. 2011 Oct 7;17(37):4166-73. doi: 10.3748/wjg.v17.i37.4166.
PubMed 22072847
Grevenitis P, Thomas A, Lodhia N. Medical Therapy for Inflammatory Bowel Disease. Surg Clin North Am. 2015 Dec;95(6):1159-82, vi. doi: 10.1016/j.suc.2015.08.004. Epub 2015 Oct 23.
PubMed 26596920
Gomez-Gomez GJ, Masedo A, Yela C, Martinez-Montiel Mdel P, Casis B. Current stage in inflammatory bowel disease: What is next? World J Gastroenterol. 2015 Oct 28;21(40):11282-303. doi: 10.3748/wjg.v21.i40.11282.
PubMed 26525013
Haus E, Sackett-Lundeen L, Smolensky MH. Rheumatoid arthritis: circadian rhythms in disease activity, signs and symptoms, and rationale for chronotherapy with corticosteroids and other medications. Bull NYU Hosp Jt Dis. 2012;70 Suppl 1:3-10.
PubMed 23259651
Perri D, Cole DE, Friedman O, Piliotis E, Mintz S, Adhikari NK. Azathioprine and diffuse alveolar haemorrhage: the pharmacogenetics of thiopurine methyltransferase. Eur Respir J. 2007 Nov;30(5):1014-7. doi: 10.1183/09031936.00026107.
PubMed 17978158
Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
PubMed 40013523
Swanson GR, Biglin M, Raff H, Chouhan V, Jochum S, Shaikh M, Francey L, Bishehsari F, Hogenesch J, Keshavarzian A. Impact of Chronotherapy on 6-Mercaptopurine Metabolites in Inflammatory Bowel Disease: A Pilot Crossover Trial. Clin Transl Gastroenterol. 2023 Feb 1;14(2):e00549. doi: 10.14309/ctg.0000000000000549.
PubMed 36730289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Inflammatory Bowel Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chronotherapy in Inflammatory Bowel Disease
ClinicalTrials.gov ID: NCT04304950
Acronym / sponsor ID: 16040505
Conditions: Inflammatory Bowel Diseases
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: 25 Apr 2016 (actual)
Primary completion: Dec 2021 (actual)
Study completion: Apr 2023 (actual)
First posted: 12 Mar 2020 (actual)
Results: Posted 27 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The Investigator hypothesize that administration time of immunomodulators (IMs) during the day can affect the clinical outcomes in IBD patients.

Specific Aims Include:

Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect the subclinical markers of inflammation related to disease.
Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect endoscopic outcomes.
Determine whether morning vs. evening dosing of IMs affect their biochemical side effects, as is routinely monitored as part of the patients' clinical care.
Determine if outcomes correlate with patients' chronotype, as determined by standard questionnaires (the Munich Chronotype Questionnaire).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized to one of two groups: Evening Time or Morning Time. Participants are used as their own control. The evening time group will take their medication in the evening and the morning time group will take the medication in the morning.

Arm	Type	Receives
Morning	Experimental	Drug: Morning GroupParticipants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the evening were assigned to the morning group. Instead of taking their medication at their usual PM time, they were instructed to take their medications in the morning for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol.
Evening	Experimental	Drug: Evening GroupParticipants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the morning were assigned to the evening group. Instead of taking their medication at their usual AM time, they were instructed to take their medications in the evening for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Above the ages of 18
Diagnosis of Crohn's Disease or Ulcerative Colitis
Currently taking azathioprine or 6-mercaptopurine
Willing to sign study consent form

Key exclusion criteria (5 listed)

Vulnerable population (pregnant, prisoner, non-English speaking or cognitively impaired)
Breastfeeding subject
Have a history of complications related to immunomodulatory therapy
Participating in other research studies involving research interventions
Treated with dual corticosteroid and immunomodulatory therapy

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
Evening GroupParticipants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.	Drug	Evening
Morning GroupParticipants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.	Drug	Morning

Primary outcome

Thioguanine Levels in Blood (Morning Versus Evening Dosing)
Time frame: 10 weeks post baseline visit.
This is to examine if the intervention results in a greater level of thioguanine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.
Harvey Bradshaw Activity Index
Time frame: 10 weeks post baseline visit.
Harvey Bradshaw Activity Index has 5 questions. The final score is totaled and will fall into the following categories, which are used to define the severity of the disease: >16 severe diseases, 8-16 moderate disease, 5-7 mild disease, <5 remission. Scores range from 0 ( lowest possible score) to 17.
Short Inflammatory Bowel Disease Questionnaire
Time frame: 10 weeks post baseline visit.
Quality of Life Measure Score:1-7 (The higher the number the greater the quality of life)
6-Methylmercaptopurine Levels in Blood
Time frame: 10 weeks post baseline visit.
This is to examine if the intervention results in a lower level of 6-Methylmercaptopurine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.

1 secondary outcome

Munich Chronotype Questionnaire ( MCTQ)
Time frame: 10 weeks post baseline visit.

Results and safety

Results posted to the registry on 27 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evening Group Medication Administration	19	18
Morning Group Administration	9	8

Primary outcome: Thioguanine Levels in Blood (Morning Versus Evening Dosing)

Time frame: 10 weeks post baseline visit.. Mean (Standard Deviation). Unit: pmol/8 x 10^8 RBC

Measure	Evening Group Medication Administration n = 18	Morning Group Medication Administration n = 8
Value	175.04 (106.89)	225.65 (155.05)

Population analysed: During the analysis, the PI and study team grouped participants by their AM and PM medication administration, regardless of what condition or medication they were on. UC and CD are types of IBD, so the analysis focuses on timing of medication in IBD. Unable to find and recruit UC patients on 6-MP.

Primary outcome: Harvey Bradshaw Activity Index

Time frame: 10 weeks post baseline visit.. Mean (Standard Deviation). Unit: units on a scale

Measure	Evening Group Medication Administration n = 18	Morning Group Medication Administration n = 8
Value	2.15 (1.71)	3.09 (2.71)

Primary outcome: Short Inflammatory Bowel Disease Questionnaire

Time frame: 10 weeks post baseline visit.. Mean (Standard Deviation). Unit: units on a scale

Measure	Evening Group Medication Administration n = 18	Morning Group Medication Administration n = 8
Value	5.83 (0.56)	5.91 (0.63)

Population analysed: During the analysis participants were grouped by AM and PM administration. UC and CD are types of IBD. The study team was unable to recruit Ulcerative Colitis individuals on 6-MP as was originally intended.

Primary outcome: 6-Methylmercaptopurine Levels in Blood

Time frame: 10 weeks post baseline visit.. Mean (Standard Deviation). Unit: pmol/8 x 10 ^8 RBC

Measure	Evening Group Medication Administration n = 18	Morning Group Medication Administration n = 8
Value	2395.27 (2880.26)	825.15 (1023.34)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year, 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evening Group Medication Administration	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Morning Group Medication Administration	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): This was a single-center study with a limited number of IBD subjects that focused on metabolite levels and not clinical efficacy. Larger multicenter studies are needed since this was a "proof of concept" pilot study. Second, the overall dose of AZA/6-MP used in this study was low. Third, the study design relied on patient compliance with medication timing and circadian rhythms were assessed only by questionnaires.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16266194Ardizzone S, Bianchi Porro G. Biologic therapy for inflammatory bowel disease. Drugs. 2005;65(16):2253-86. doi: 10.2165/00003495-200565160-00002.
Background: PubMed 11218242Belaiche J, Desager JP, Horsmans Y, Louis E. Therapeutic drug monitoring of azathioprine and 6-mercaptopurine metabolites in Crohn disease. Scand J Gastroenterol. 2001 Jan;36(1):71-6. doi: 10.1080/00365520150218084.
Background: PubMed 22072847Bradford K, Shih DQ. Optimizing 6-mercaptopurine and azathioprine therapy in the management of inflammatory bowel disease. World J Gastroenterol. 2011 Oct 7;17(37):4166-73. doi: 10.3748/wjg.v17.i37.4166.
Background: PubMed 26596920Grevenitis P, Thomas A, Lodhia N. Medical Therapy for Inflammatory Bowel Disease. Surg Clin North Am. 2015 Dec;95(6):1159-82, vi. doi: 10.1016/j.suc.2015.08.004. Epub 2015 Oct 23.
Background: PubMed 26525013Gomez-Gomez GJ, Masedo A, Yela C, Martinez-Montiel Mdel P, Casis B. Current stage in inflammatory bowel disease: What is next? World J Gastroenterol. 2015 Oct 28;21(40):11282-303. doi: 10.3748/wjg.v21.i40.11282.
Background: PubMed 23259651Haus E, Sackett-Lundeen L, Smolensky MH. Rheumatoid arthritis: circadian rhythms in disease activity, signs and symptoms, and rationale for chronotherapy with corticosteroids and other medications. Bull NYU Hosp Jt Dis. 2012;70 Suppl 1:3-10.
Background: PubMed 17978158Perri D, Cole DE, Friedman O, Piliotis E, Mintz S, Adhikari NK. Azathioprine and diffuse alveolar haemorrhage: the pharmacogenetics of thiopurine methyltransferase. Eur Respir J. 2007 Nov;30(5):1014-7. doi: 10.1183/09031936.00026107.
Derived from this study: PubMed 40013523Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
Derived from this study: PubMed 36730289Swanson GR, Biglin M, Raff H, Chouhan V, Jochum S, Shaikh M, Francey L, Bishehsari F, Hogenesch J, Keshavarzian A. Impact of Chronotherapy on 6-Mercaptopurine Metabolites in Inflammatory Bowel Disease: A Pilot Crossover Trial. Clin Transl Gastroenterol. 2023 Feb 1;14(2):e00549. doi: 10.14309/ctg.0000000000000549.
MacDermott, R. P. (2016). 6-mercaptopurine (6-MP) metabolite monitoring and TPMT testingin the treatment of inflammatory bowel disease with 6-MP or azathioprine. RetrievedMarch 6, 2016, from UpToDate websiteLink provided by the sponsor.
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.

Garth Swanson, MD principal investigator

Rush University Medical Center

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 Evening Group and Morning Group in people with Inflammatory Bowel Diseases, run by Rush University Medical Center at 1 site in United States.

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 5 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 27 Jun 2023. 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Thioguanine Levels in Blood (Morning Versus Evening Dosing) (time frame: 10 weeks post baseline visit.). The study lists 4 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 NCT04304950, 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 27 Jun 2023.