Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-1638 | Registry Identifier | WHO |
Not provided
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The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.
Research on drugs that affect bone homeostasis have shown changes in levels of bone formation and resorption biomarkers. This study will evaluate the effect of dexlansoprazole on bone homeostasis by assessing changes in biochemical markers of bone formation and bone resorption. This study will also assess changes in bone mineral density by dual-energy x-ray absorptiometry scan and other markers of bone homeostasis.
The study will consist of a 12-week screening period, a 26-week treatment period with a total of 5 visits during the treatment period and a follow-up visit at Week 52 for bone mineral density assessment.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26. |
|
| Dexlansoprazole 60 mg | Experimental | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
|
| Esomeprazole 40mg | Active Comparator | Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexlansoprazole | Drug | Dexlansoprazole 60 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP) | The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL). | Baseline and Week 26 |
| Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX) | The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL. | Baseline and Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated | The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent | Baseline and Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in P1NP at Week 13 | Serum samples for P1NP were analyzed using an electrochemiluminescence immunoassay measured in ng/mL. | Baseline and Week 13 |
| Percent Change From Baseline in CTX at Week 13 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30445008 | Derived | Hansen KE, Nieves JW, Nudurupati S, Metz DC, Perez MC. Dexlansoprazole and Esomeprazole Do Not Affect Bone Homeostasis in Healthy Postmenopausal Women. Gastroenterology. 2019 Mar;156(4):926-934.e6. doi: 10.1053/j.gastro.2018.11.023. Epub 2018 Nov 13. |
| Label | URL |
|---|---|
| Dexilant Package Insert | View source |
Not provided
Healthy post-menopausal women were enrolled equally in 1 of 3 treatment groups, once a day, placebo, 60 mg dexlansoprazole delayed-release capsules or 40 mg esomeprazole delayed-release capsules.
Participants took part in the study at 10 investigative sites in the United States from 01 November 2010 (first subject signed informed consent form) to 1 February 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26. |
| FG001 | Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
| FG002 | Esomeprazole 40 mg | Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
|
| |||||||||||||||||||||||||||
| Calcium Absorption Substudy |
|
Safety set includes all randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number analyzed are the participants with data available for Age |
| 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 | Percent Change From Baseline to Week 26 in Bone Formation Marker Aminoterminal Propeptide of Type 1 Collagen (P1NP) | The percent change in bone formation marker P1NP measured at week 26 from P1NP measured at baseline. Serum samples for P1NP were analyzed at a central laboratory for bone biomarker P1NP using an electrochemiluminescence immunoassay measured in nanograms per milliliter (ng/mL). | Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure. | Posted | Median | Full Range | percent change | Baseline and Week 26 |
|
First dose of study drug and within 30 days of the last dose of study drug (Up to 30 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo-matching capsules, orally, once daily for up to 26 weeks. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
Not provided
| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D064747 | Lansoprazole |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Esomeprazole | Drug | Esomeprazole 40 mg capsules |
|
|
| Placebo | Drug | Placebo-matching capsules |
|
| Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP) | The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L). | Baseline and Week 26 |
Plasma samples were analyzed for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL.
| Baseline and Week 13 |
| Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26 | DXA is a means of measuring BMD through x-ray. | Baseline and Week 26 |
| Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26 | DXA is a means of measuring BMD through x-ray. | Baseline and Week 26 |
| Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26 | DXA is a means of measuring BMD through x-ray. | Baseline and Week 26 |
| Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52 | DXA is a means of measuring BMD through x-ray. | Week 26 and Week 52 |
| Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52 | DXA is a means of measuring BMD through x-ray. | Week 26 and Week 52 |
| Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52 | Week 26 and Week 52 |
| Number of Participants With Fracture Including Vertebral Fracture During Study Treatment | Baseline up to Week 26 |
| Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26 | Baseline and Week 26 |
| Change From Baseline in Parathyroid Hormone (PTH) at Week 26 | Baseline and Week 26 |
| Change From Baseline in Serum Calcium at Week 26 | Baseline and Week 26 |
| Change From Baseline in Serum Phosphorus at Week 26 | Baseline and Week 26 |
| Change From Baseline in Serum Magnesium at Week 26 | Baseline and Week 26 |
| Change From Baseline in Urine Magnesium at Week 26 | Baseline and Week 26 |
| Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level | Baseline and Week 26 |
| Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26 | Baseline and Week 26 |
| Walnut Creek |
| California |
| United States |
| Lakewood | Colorado | United States |
| Hialeah | Florida | United States |
| Jupiter | Florida | United States |
| Bethesda | Maryland | United States |
| Albuquerque | New Mexico | United States |
| Spartanburg | South Carolina | United States |
| Austin | Texas | United States |
| San Antonio | Texas | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| Lost to Follow-up |
|
| Voluntary Withdrawal |
|
| Other Reason Not Specified |
|
| Randomized, Not Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Dexlansoprazole 60 mg |
Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
| BG002 | Esomeprazole 40 mg | Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Full Range | cm |
|
| Weight | Mean | Full Range | kg |
|
| Body Mass Index (BMI) | Mean | Full Range | kg/m^2 |
|
| Smoking Classification | Count of Participants | Participants |
|
| Alcohol Classification | Count of Participants | Participants |
|
| Caffeine Consumption | Count of Participants | Participants |
|
| Calcium at Screening Visit | Mean | Full Range | mg/dL |
|
| Vitamin D at Screening Visit | Mean | Full Range | ng/mL |
|
| OG001 | Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
| OG002 | Esomeprazole 40 mg | Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. |
|
|
|
| Primary | Percent Change From Baseline to Week 26 in Bone Resorption Marker C-telopeptide of Collagen Cross-links (CTX) | The percent change in bone resorption marker CTX measured at week 26 from CTX measured at baseline. Plasma samples were analyzed at a central laboratory for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL. | Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure. | Posted | Median | Full Range | percent change | Baseline and Week 26 |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 26 in Urine N-telopeptide of Collagen Cross-links (NTx) Calculated | The percent change in bone resorption marker NTx measured at week 26 from NTx measured at baseline. Urine samples were analyzed at a central laboratory for NTx using an enzyme-linked immunosorbent assay calculated as (nmol BCE/mmol creatinine). BCE=bone collagen equivalent | Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure. | Posted | Median | Full Range | percent change | Baseline and Week 26 |
|
|
|
|
| Secondary | Percent Change From Baseline to Week 26 in Bone-specific Alkaline Phosphatase (BsAP) | The percent change in bone formation marker BsAP measured at week 26 from BsAP measured at baseline. Serum samples were analyzed at a central laboratory for bone biomarker BsAP using an enzyme immunoassay measured in units per liter (U/L). | Participants from the Pharmacodynamic Set, all randomized participants who received study drug with evaluable calcium absorption data at Day 1 and Week 26, with data available for this outcome measure. | Posted | Median | Full Range | percent change | Baseline and Week 26 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in P1NP at Week 13 | Serum samples for P1NP were analyzed using an electrochemiluminescence immunoassay measured in ng/mL. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 13 |
|
|
|
| Other Pre-specified | Percent Change From Baseline in CTX at Week 13 | Plasma samples were analyzed for bone biomarker CTX using an electrochemiluminescence immunoassay measured in ng/mL. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 13 |
|
|
|
| Other Pre-specified | Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 26 | DXA is a means of measuring BMD through x-ray. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Percent Change From Baseline in Total Hip BMD Measured by DXA at Week 26 | DXA is a means of measuring BMD through x-ray. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Percent Change From Baseline in Lumbar Spine BMD Measured by DXA at Week 26 | DXA is a means of measuring BMD through x-ray. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Percent Change From Week 26 in Femoral Neck BMD Measured by DXA at Week 52 | DXA is a means of measuring BMD through x-ray. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Week 26 and Week 52 |
|
|
|
| Other Pre-specified | Percent Change From Weeks 26 in Total Hip BMD Measured by DXA at Week 52 | DXA is a means of measuring BMD through x-ray. | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Week 26 and Week 52 |
|
|
|
| Other Pre-specified | Percent Change From Weeks 26 in Lumbar Spine BMD Measured by DXA at Week 52 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | percent change | Week 26 and Week 52 |
|
|
|
| Other Pre-specified | Number of Participants With Fracture Including Vertebral Fracture During Study Treatment | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. | Posted | Number | participants | Baseline up to Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in 24-hour Urinary Calcium Excretion at Week 26 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | milligram per day (mg/d) | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in Parathyroid Hormone (PTH) at Week 26 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in Serum Calcium at Week 26 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in Serum Phosphorus at Week 26 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in Serum Magnesium at Week 26 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | milliequivalent per liter (meq/L) | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in Urine Magnesium at Week 26 | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | meq/L | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline to Week 26 in Vitamin D3 (25-OH-D) Level | The pharmacodynamic set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The pharmacodynamic set where data for baseline and post-baseline assessments was available. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Week 26 |
|
|
|
| Other Pre-specified | Change From Baseline in Intestinal Calcium Absorption by True Fractional Calcium Absorption (TFCA) in a Subset of Participants at Week 26 | The PD set included participants from the safety set who had baseline and postbaseline values for any of the primary or secondary endpoints. The PD set included participants with evaluable calcium absorption data on Day-1 and Week 26. | Posted | Mean | Standard Deviation | mg/d | Baseline and Week 26 |
|
|
|
| 41 |
| 0 |
| 41 |
| 6 |
| 41 |
| EG001 | Dexlansoprazole 60 mg | Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks. | 0 | 38 | 1 | 38 | 8 | 38 |
| EG002 | Esomeprazole 40mg | Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks. | 0 | 35 | 0 | 35 | 9 | 35 |
| EG003 | Calcium Absorption Sub Study: Placebo | Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 calcium (42 Ca) 3 milligram (mg), intravenously and 44 calcium (44 Ca) 8 mg, orally, once on Day-1 and Week 26. | 0 | 14 | 0 | 14 | 3 | 14 |
| EG004 | Calcium Absorption Sub Study: Dexlansoprazole 60 mg | Following the main study Participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. | 0 | 10 | 0 | 10 | 4 | 10 |
| EG005 | Calcium Absorption Sub Study: Esomeprazole 40 mg | Following the main study participants had the option to participate in the calcium absorption sub study to receive calcium isotope 42 Ca 3 mg, intravenously and 44 Ca 8 mg, orally, once on Day-1 and Week 26. | 0 | 10 | 0 | 10 | 5 | 10 |
| Urinary tract infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.0 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009853 | Omeprazole |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Current smoker |
|
| Ex-smoker |
|
| Current drinker |
|
| Ex-drinker |
|
| Not had caffeine consumption |
|
| Difference |
| 22.025 |
| 2-Sided |
| 95 |
| 8.357 |
| 35.714 |
Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method. |
| Superiority or Other (legacy) |
| Difference |
| 11.6 |
| 2-Sided |
| 95 |
| -2.7 |
| 28.3 |
Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method. |
| Superiority or Other (legacy) |
| Difference |
| 7.23 |
| 2-Sided |
| 95 |
| 0.59 |
| 12.86 |
Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method. |
| Superiority or Other (legacy) |
|
| Change at Week 26 |
|
|
| Change at Week 26 |
|
|
| Change at Week 26 |
|
|
| Change at Week 26 |
|
|
| Change at Week 26 |
|
|
| Change at Week 26 |
|
|
|