Malignant TumorNCT04926545
XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study)
A study testing Xiao Chai Hu Tang (XCHT), Raloxifene and FOLFIRI regimen in people with Malignant Tumor and Diarrhea, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Run-in safety study, to determine the safety of co-administration of irinotecan, raloxifene, and Xiao Chai Hu Tang (XCHT), and to optimize the blood collection time points for pharmacokinetic (PK) study for another randomized control trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Tumor, Diarrhea
- What is being tested?
- Xiao Chai Hu Tang (XCHT), Raloxifene and FOLFIRI regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2021to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant tumor confirmed by histology or cytology;
- Postmenopausal women, after bilateral oophorectomy; age > 60 years old, or age < 60 years old with menopause for more than 1 year;
- Age ≥ 18 years old, ≤ 75 years old;
- ECOG score of the patient ≤ 2 points;
- Never been treated with irinotecan;
- Plan to receive at least 3 rounds of FOLFIRI chemotherapy determined by physicians;
Show all 24Show fewer
- Normal organ functions can meet the requirements for systemic chemotherapy:
- Reserve functions of normal bone marrow: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90 g/L;
- Normal renal functions: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min;
- Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤ 2.5 × ULN; If abnormal hepatic functions are caused by a potentially malignant tumor, and AST ＆ ALT ≤ 5 × ULN;
- Patient is willing to participate and cooperate to complete the questions in the case report form;
- Patient can understand and sign the informed consent form, is well compliant, and can be followed up.
- Cohort B: cancer patients who experienced irinotecan -induced diarrhea (grade >2)
- Malignant tumor confirmed by histology or cytology;
- Age ≥ 18 years old, ≤ 75 years old;
- ECOG score of the patient ≤ 2 points;
- Patients who have diarrhea worse than grade 2 due to irinotecan chemotherapy (the last dose of irinotecan is administered within 1 month);
- Patients who plan to receive 3 rounds of FOLFIRI chemotherapy;
- Normal organ functions can meet the requirements for systemic chemotherapy:
- Reserve functions of normal bone marrow: absolute neutrophil count (ANC) ≥ 1.5×109/L, PLT ≥ 100×109/L, hemoglobin ≥ 90g/L;
- Normal renal functions: serum creatinine ≤ 1.5mg/dl (133μmol/L) and/or creatinine clearance ≥ 60ml/min;
- Normal hepatic functions: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value (ULN), serum aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤ 2.5 × ULN; If abnormal hepatic functions are caused by a potentially malignant tumor, and AST ＆ ALT ≤ 5 × ULN;
- Patient is willing to participate and cooperate to complete the questions in the case report form;
- Patients can understand and sign the informed consent form, is well compliant, and can be followed up.
Who cannot join
- Patients with diagnosed depression, obsession or/and schizophrenia;
- Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
- Patient with active tuberculosis and other uncontrolled infections;
- Patient has previously received radiotherapy on the abdominal cavity and pelvic cavity;
- Pregnant or lactating women;
- Patient previously had or is now having thromboembolic (blood clotting) events.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
About this study
Official title: Mechanistic and Pharmacokinetic Studies of Classical Chinese Formula Xiao Chai Hu Tang Against Irinotecan-Induced Gut Toxicities(Clinical Study Part:Run-in Safety Study)
Run-in safety study, to determine the safety of co-administration of irinotecan, raloxifene, and Xiao Chai Hu Tang (XCHT), and to optimize the blood collection time points for pharmacokinetic (PK) study for another randomized control trial.
Read the detailed description
There will be two cohorts with a total of 24 patients in this study. Cohort A will enroll 6 naïve postmenopausal female patients who have never received irinotecan treatment before. Patients in this group will have 4 rounds of studies following different protocol to determine (1) the impact of XCHT on raloxifene PK (Round 0, co-administration of XCHT and raloxifene); (2) the impact of XCHT on irinotecan PK (Round 1, co-administration of XCHT and standard FOLFIRI); (3) the safety of co- administration of XCHT, raloxifene, and FOLFIRI and evaluation of raloxifene as a probe for XCHT treatment to prevent irinotecan-induced severe delayed-onset diarrhea (Round 2 and 3, co-administration of XCHT, raloxifene, and standard FOLFIRI). The reason to recruit postmenopausal women is that these patients usually take raloxifene to prevent osteoporosis and the risk of raloxifene is expected to be limited.
Cohort B will recruit 18 patients who were treated with irinotecan previously and have at least one diarrhea episode with a severity of ≥grade 2. The reason we propose to recruit patients who had diarrhea induced by irinotecan is that these patients are supposed to be sensitive to irinotecan so that we can determine the PK changes and safety. Patients in this group will have 3 rounds of FOLFIRI chemotherapy to determine (1) the impact of FOLFIRI on raloxifene PK (Round 1, co-administration of FOLFIRI with raloxifene); (2) the complete PK profile of SN-38, SN-38G, raloxifene, raloxifene-glucuronide, and XCHT components (Round 2, co- administration of FOLFIRI with XCHT and raloxifene); and (3) the safety of co-administration of XCHT, raloxifene, and FOLFIRI in sensitive patients and evaluation of raloxifene as a probe for XCHT treatment to prevent irinotecan-induced diarrhea (Round 3, co-administration of XCHT, raloxifene and standard FOLFIRI).
- Conditions
- Malignant Tumor, Diarrhea
- Being tested
- Xiao Chai Hu Tang (XCHT), Raloxifene, FOLFIRI regimen
- Keywords
- Malignant tumor, Irinotecan, chemotherapy-induced diarrhea, Classical Chinese Formula, safety
- Medical subject headings
- Neoplasms, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiao Chai Hu Tang (XCHT)Drug
Also called Xiao Chai Hu Tang granules from Nin Jiom Medicine Manufactory (Hong Kong) Ltd.
XCHT 9g, po qd, 3 days before each cycle of chemotherapy for 5 days, except the 1st cycle of chemotherapy for irinotecan used cohort patients.
Additional XCHT, 9g qd will be orally administrated for 4 days during the Round 0 study for irinotecan naive cohort patients.
RaloxifeneOther
Also called Evista from Eli Lilly
Raloxifene 60mg po, used as probe for pharmacokinetic testing. For irinotecan naive cohort patients, raloxifene 60mg will be orally administrated on Day 1 and Day 5 (4th day of XCHT administration) during round 0 study, Day 3 (the day before chemotherapy) during round 2 and round 3 study. For irinotecan used cohort patients, raloxifene 60mg will be orally administrated on Day 1 (irinotecan using day) during round 1 study, Day 4 (irinotecan using day) during round 2 study, and Day 3 (the day before chemotherapy) during round 3 study.
FOLFIRI regimenDrug
Also called Irinotecan Hydrochloride from Pfizer+Folinic acid+5-fluorouracil (5-FU)
Patients will receive 3 cycles of FOLFIRI regimen for chemotherapy. Irinotecan intravenous (IV) infusion (180 mg/m2) through a drip into the bloodstream over 90 minutes. Folinic acid (400 mg/m2) IV infusion through a drip into the bloodstream over 2 hours. 5-fluorouracil (5-FU) IV bolus (400 mg/m2) into the bloodstream over 5 minutes, followed by 5-FU (2400 mg/m2) continuous IV infusion through a drip or pump into the bloodstream for 46-48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan naive cohort | Experimental | This cohort will enroll 6 postmenopausal female patients who have never received irinotecan treatment before. Patients in irinotecan naive cohort will receive 3 cycles of FOLFIRI chemotherapy, during which 4 rounds of pharmacokinetic studies will be conducted.
Round 0 (before chemotherapy): pharmacokinetic testing (raloxifene 60mg as probe) before XCHT administration, then XCHT for 4 days with pharmacokinetic testing (raloxifene 60mg as probe) on the 4th day of XCHT administration.
Round 1(1st cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (without raloxifene) on day 4.
Round 2 (2nd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 3.
Round 3 (3rd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 3. Receives: Drug: Xiao Chai Hu Tang (XCHT); Other: Raloxifene; Drug: FOLFIRI regimen |
| Irinotecan used cohort | Experimental | This cohort will recruit 18 patients who were treated with irinotecan previously and have at least one diarrhea episode with a severity of more than grade 2. Patients in irinotecan used cohort will receive 3 cycles of FOLFIRI chemotherapy, during which 3 rounds of pharmacokinetic studies will be conducted.
Round 1(1st cycle of chemotherapy): FOLFIRI, with pharmacokinetic testing (raloxifene 60mg as probe) on the first day of chemotherapy.
Round 2 (2nd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 4.
Round 3 (3rd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 3. Receives: Drug: Xiao Chai Hu Tang (XCHT); Other: Raloxifene; Drug: FOLFIRI regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average trajectory of irinotecan, raloxifene, XCHT and their metabolites (14 compounds)
Plasma concentration for each compounds will be tested at 8 points for each Round.
Measured: The blood samples (2.0 ml) will be collected at 8 points for each Round (hour 0, hour 0.5, hour 1, hour 2, hour 4, hour 6, hour 8, and hour 24 after raloxifene administration)
Secondary outcomes (4)
incidences of grade ≥3 diarrhea
The diarrhea severity will be evaluated following standard criteria in NCI-CTC AE 5.0
Measured: Through study completion, an average of 2 months
occult blood test for stool
occult blood test for stool, reported as negative, weak positive, and positive.
Measured: Through study completion, an average of 2 months
incidence of other chemo-related adverse effects
Other adverse reactions will be evaluated following standard criteria in NCI-CTC AE 5.0
Measured: Through study completion, an average of 2 months.
incidence of diarrhea (grade ≥2)
The diarrhea severity will be evaluated following standard criteria in NCI-CTC AE 5.0 Grade 2 is defined as Stool is increased by 4-6 times each day relative to baseline; discharge from stoma moderately increased.
Measured: Through study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start16 Jul 2021
- Primary completion20 Jul 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston
- Responsible party
- Sponsor
- Investigators
- Haibo Zhang, Prof, Principal investigator, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926545
- Sponsor's protocol ID
- 2021KT1005
- Other IDs
- 81961128028
- Status last verified
- Apr 2024
- First submitted
- 30 May 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic and Pharmacokinetic Studies of Classical Chinese Formula Xiao Chai Hu Tang Against Irinotecan-Induced Gut Toxicities(Clinical Study Part:Run-in Safety Study)
- ClinicalTrials.gov ID
- NCT04926545
- Acronym / sponsor ID
- 2021KT1005
- Conditions
- Malignant Tumor, Diarrhea
- Keywords
- Malignant tumor, Irinotecan, chemotherapy-induced diarrhea, Classical Chinese Formula, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- University of Houston
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 15 Jun 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.
Run-in safety study, to determine the safety of co-administration of irinotecan, raloxifene, and Xiao Chai Hu Tang (XCHT), and to optimize the blood collection time points for pharmacokinetic (PK) study for another randomized control trial.
Detailed description
There will be two cohorts with a total of 24 patients in this study. Cohort A will enroll 6 naïve postmenopausal female patients who have never received irinotecan treatment before. Patients in this group will have 4 rounds of studies following different protocol to determine (1) the impact of XCHT on raloxifene PK (Round 0, co-administration of XCHT and raloxifene); (2) the impact of XCHT on irinotecan PK (Round 1, co-administration of XCHT and standard FOLFIRI); (3) the safety of co- administration of XCHT, raloxifene, and FOLFIRI and evaluation of raloxifene as a probe for XCHT treatment to prevent irinotecan-induced severe delayed-onset diarrhea (Round 2 and 3, co-administration of XCHT, raloxifene, and standard FOLFIRI). The reason to recruit postmenopausal women is that these patients usually take raloxifene to prevent osteoporosis and the risk of raloxifene is expected to be limited.
Cohort B will recruit 18 patients who were treated with irinotecan previously and have at least one diarrhea episode with a severity of ≥grade 2. The reason we propose to recruit patients who had diarrhea induced by irinotecan is that these patients are supposed to be sensitive to irinotecan so that we can determine the PK changes and safety. Patients in this group will have 3 rounds of FOLFIRI chemotherapy to determine (1) the impact of FOLFIRI on raloxifene PK (Round 1, co-administration of FOLFIRI with raloxifene); (2) the complete PK profile of SN-38, SN-38G, raloxifene, raloxifene-glucuronide, and XCHT components (Round 2, co- administration of FOLFIRI with XCHT and raloxifene); and (3) the safety of co-administration of XCHT, raloxifene, and FOLFIRI in sensitive patients and evaluation of raloxifene as a probe for XCHT treatment to prevent irinotecan-induced diarrhea (Round 3, co-administration of XCHT, raloxifene and standard FOLFIRI).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irinotecan naive cohort | Experimental | Drug: Xiao Chai Hu Tang (XCHT), Other: Raloxifene, Drug: FOLFIRI regimenThis cohort will enroll 6 postmenopausal female patients who have never received irinotecan treatment before. Patients in irinotecan naive cohort will receive 3 cycles of FOLFIRI chemotherapy, during which 4 rounds of pharmacokinetic studies will be conducted. Round 0 (before chemotherapy): pharmacokinetic testing (raloxifene 60mg as probe) before XCHT administration, then XCHT for 4 days with pharmacokinetic testing (raloxifene 60mg as probe) on the 4th day of XCHT administration. Round 1(1st cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (without raloxifene) on day 4. Round 2 (2nd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 3. Round 3 (3rd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 3. |
| Irinotecan used cohort | Experimental | Drug: Xiao Chai Hu Tang (XCHT), Other: Raloxifene, Drug: FOLFIRI regimenThis cohort will recruit 18 patients who were treated with irinotecan previously and have at least one diarrhea episode with a severity of more than grade 2. Patients in irinotecan used cohort will receive 3 cycles of FOLFIRI chemotherapy, during which 3 rounds of pharmacokinetic studies will be conducted. Round 1(1st cycle of chemotherapy): FOLFIRI, with pharmacokinetic testing (raloxifene 60mg as probe) on the first day of chemotherapy. Round 2 (2nd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 4. Round 3 (3rd cycle of chemotherapy): XCHT for 5 days and FOLFIRI on day 4, with pharmacokinetic testing (raloxifene 60mg as probe) on day 3. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Malignant tumor confirmed by histology or cytology;
- Postmenopausal women, after bilateral oophorectomy; age > 60 years old, or age < 60 years old with menopause for more than 1 year;
- Age ≥ 18 years old, ≤ 75 years old;
- ECOG score of the patient ≤ 2 points;
- Never been treated with irinotecan;
Key exclusion criteria (6 listed)
- Patients with diagnosed depression, obsession or/and schizophrenia;
- Patients with diagnosed inflammatory bowel diseases (including Crohn's disease, ulcerative colitis)
- Patient with active tuberculosis and other uncontrolled infections;
- Patient has previously received radiotherapy on the abdominal cavity and pelvic cavity;
- Pregnant or lactating women;
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 Chai Hu Tang (XCHT)Also: Xiao Chai Hu Tang granules from Nin Jiom Medicine Manufactory (Hong Kong) Ltd.XCHT 9g, po qd, 3 days before each cycle of chemotherapy for 5 days, except the 1st cycle of chemotherapy for irinotecan used cohort patients. Additional XCHT, 9g qd will be orally administrated for 4 days during the Round 0 study for irinotecan naive cohort patients. | Drug | Irinotecan naive cohort, Irinotecan used cohort |
| RaloxifeneAlso: Evista from Eli LillyRaloxifene 60mg po, used as probe for pharmacokinetic testing. For irinotecan naive cohort patients, raloxifene 60mg will be orally administrated on Day 1 and Day 5 (4th day of XCHT administration) during round 0 study, Day 3 (the day before chemotherapy) during round 2 and round 3 study. For irinotecan used cohort patients, raloxifene 60mg will be orally administrated on Day 1 (irinotecan using day) during round 1 study, Day 4 (irinotecan using day) during round 2 study, and Day 3 (the day before chemotherapy) during round 3 study. | Other | Irinotecan naive cohort, Irinotecan used cohort |
| FOLFIRI regimenAlso: Irinotecan Hydrochloride from Pfizer+Folinic acid+5-fluorouracil (5-FU)Patients will receive 3 cycles of FOLFIRI regimen for chemotherapy. Irinotecan intravenous (IV) infusion (180 mg/m2) through a drip into the bloodstream over 90 minutes. Folinic acid (400 mg/m2) IV infusion through a drip into the bloodstream over 2 hours. 5-fluorouracil (5-FU) IV bolus (400 mg/m2) into the bloodstream over 5 minutes, followed by 5-FU (2400 mg/m2) continuous IV infusion through a drip or pump into the bloodstream for 46-48 hours. | Drug | Irinotecan naive cohort, Irinotecan used cohort |
Primary outcome
Average trajectory of irinotecan, raloxifene, XCHT and their metabolites (14 compounds)
Time frame: The blood samples (2.0 ml) will be collected at 8 points for each Round (hour 0, hour 0.5, hour 1, hour 2, hour 4, hour 6, hour 8, and hour 24 after raloxifene administration)
Plasma concentration for each compounds will be tested at 8 points for each Round.
4 secondary outcomes
incidences of grade ≥3 diarrhea
Time frame: Through study completion, an average of 2 months
occult blood test for stool
Time frame: Through study completion, an average of 2 months
incidence of other chemo-related adverse effects
Time frame: Through study completion, an average of 2 months.
incidence of diarrhea (grade ≥2)
Time frame: Through study completion, an average of 2 months.
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 30 Jul 2024.
- 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.
Haibo Zhang, Prof principal investigator
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xiao Chai Hu Tang (XCHT), Raloxifene and FOLFIRI regimen in people with Malignant Tumor and Diarrhea, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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 24 inclusion and 6 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 30 Jul 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study 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?
Average trajectory of irinotecan, raloxifene, XCHT and their metabolites (14 compounds) (time frame: The blood samples (2.0 ml) will be collected at 8 points for each Round (hour 0, hour 0.5, hour 1, hour 2, hour 4, hour 6, hour 8, and hour 24 after raloxifene administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.