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The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography) scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.
The study will be a prospective randomized double-blind placebo-controlled trial of mirabegron for medical expulsive therapy (MET) in patients with a CT scan-proven ureteral stone between 4 to 10 mm undergoing expectant management. Subjects will be distributed at a 1:1 ratio between the control and treatment groups. The treatment group will receive mirabegron and the control groups will receive a placebo. Both groups will receive analgesics and hydration will be recommended. All subjects will then be followed for 30 days to determine the proportion of subjects with spontaneous passage. Patients will record narcotic usage and pain scores during this time. If there is stone persistence in the ureter based on imaging (CT scan of the abdomen and pelvis versus renal ultrasound plus KUB), then the patient will undergo ureteroscopy with stent placement. In these patients, treatment will continue while the stent is in place and patients will fill out a validated questionnaire regarding stent pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Active | Active Comparator | Mirabegron 50 mg orally once every 24 hours starting immediately |
|
| Arm 2 - Placebo | Placebo Comparator | Placebo orally once every 24 hours starting immediately |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Stone Passage Using Fisher's Exact Test | The primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale | Pain measures between treatment groups will be measured daily for each patient by using the Wong-Baker Pain Rating Scale. The Questionnaire will be observed in patients who require surgical intervention, and will be observed during study visit. A general linear model will be used to compare Wong-Baker pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
Adults unable to consent
Age less than 18
Multiple stones
Solitary kidney
Horseshoe kidney
On immunosuppressant therapy
On digoxin
Uncontrolled hypertension (Systolic blood pressure > 170, diastolic blood pressure > 110)
History of ureteral surgery or previous endoscopic procedure
Allergy to mirabegron
Current calcium antagonist or corticosteroid or tamsulosin usage
Patients already taking a beta-adrenergic agonist medication
Renal insufficiency [Glomerular Filtration Rate (GFR) less than 60]
Patients with Childs B and C liver failure
Signs of infection i. Temperature greater than 38 degrees Celsius ii. Urinalysis with any of the following positive:
Patients with chronic pain already undergoing treatment with narcotic medications
Pregnant women and nursing mothers
Prisoners
No working phone number
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| Name | Affiliation | Role |
|---|---|---|
| Wesley A. Mayer, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
Data will be published in a aggregate format after completion of study.
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33 met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Active | Mirabegron 50 mg orally once every 24 hours starting immediately Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
| FG001 | Arm 2 - Placebo | Placebo orally once every 24 hours starting immediately Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Active | Mirabegron 50 mg orally once every 24 hours starting immediately Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spontaneous Stone Passage Using Fisher's Exact Test | The primary outcome was stone passage rate at 30-days defined by either imaging (CT or Renal Ultrasound/KUB) or identification of stone using a straining device. | Posted | Count of Participants | Participants | No | 30 days |
|
The research study staff will contact the subject by phone approximately 7, 21 and 30 days after Visit 1. Research staff will assess ureteral pain, medication/strainer compliance, and adverse events. Next
Safety outcomes will be reported when they happened. Suspected serious adverse events will be graded at site by the principal investigator. Safety events will be monitored by Astellas research ethics committee, and MHRA.
Reporting of unanticipated problems will be in accordance to the current IRB guidelines and FDA regulations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 2 - Placebo | Placebo orally once every 24 hours starting immediately Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Perla Ramirez | Baylor College of Medicine | 713-798-8514 | Perla.Ramirez@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Consent form | Feb 20, 2019 | Oct 29, 2020 | Prot_SAP_ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form | Mar 8, 2019 | Dec 18, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D014517 | Ureteral Obstruction |
| D021501 | Flank Pain |
| D053039 | Ureterolithiasis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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|
|
| Placebo | Other | Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
|
| 2 months |
| BG001 | Arm 2 - Placebo | Placebo orally once every 24 hours starting immediately Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| CBC WBC | Mean | Standard Deviation | 10^9 cells/L |
|
| CBC Hgb | Mean | Standard Deviation | grams/dL |
|
| CBC Platelets | Mean | Standard Deviation | "10^10 platelets per liter |
|
| BMP Creatinine | Mean | Standard Deviation | mg/dl |
|
| BMP Potassium | Mean | Standard Deviation | mmol/L |
|
| BMP Calcium | Mean | Standard Deviation | mmol/L |
|
| Stone Size | Mean | Standard Deviation | mm |
|
| UA RBC | Mean | Standard Deviation | RBC/HPF |
|
| Gender | Count of Participants | Participants |
|
| Previous Stone | Number | count of participants |
|
| Stone Location | Count of Participants | Participants |
|
| Arm 2 - Placebo |
Placebo orally once every 24 hours starting immediately Placebo: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. |
|
|
| Secondary | Comparison of Pain Levels Between Treatment Groups Using the Wong-Baker Pain Rating Scale | Pain measures between treatment groups will be measured daily for each patient by using the Wong-Baker Pain Rating Scale. The Questionnaire will be observed in patients who require surgical intervention, and will be observed during study visit. A general linear model will be used to compare Wong-Baker pain scores between the treated and placebo groups. The model will also be used to explore associations between pain scores and demographic or clinical characteristics adjusting for treatment group. | Comparisons between arms were calculated with ttest, Wilcoxon rank sum, and Fisher's exact test. Regression assessed odds of stone passageby 30 day visit by treatment arm. Time-to-stone pass was analyzed using Kaplan-Meier curves, log rank test,Cox proportional hazards regression. Patients who didn't pass stone were censored at last follow-up date. Wong-Baker Pain Rating Scale has zero to ten range. Zero represents no pain and ten represents worst. | Posted | Mean | Full Range | units on a scale | 2 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Arm 1 - Active | Mirabegron 50 mg orally once every 24 hours starting immediately Mirabegron: Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D052878 | Urolithiasis |