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Trial record 1 of 1 for:    CW-2200-401-RD
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Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants (Osteopro)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01639222
First Posted: July 12, 2012
Last Update Posted: October 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: March 25, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Calcium Deficiency
Vitamin D Deficiency
Interventions: Drug: Calcium 500 mg and Vitamin D3 800 IU
Other: Low calcium meals

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Calcium 500 mg and Vitamin D3 800 IU

Period 1: Low calcium meals for up to 3 days.

Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.


Participant Flow:   Overall Study
    Calcium 500 mg and Vitamin D3 800 IU
STARTED   55 
COMPLETED   55 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Calcium 500 mg and Vitamin D3 800 IU

Period 1: Low calcium meals for up to 3 days.

Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.


Baseline Measures
   Calcium 500 mg and Vitamin D3 800 IU 
Overall Participants Analyzed 
[Units: Participants]
 55 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.07  (7.01) 
Gender 
[Units: Participants]
 
Female   22 
Male   33 
Region of Enrollment 
[Units: Participants]
 
Germany   55 
Height 
[Units: Cm]
Mean (Standard Deviation)
 172.71  (8.97) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 77.28  (10.06) 
Body Mass Index (BMI) 
[Units: Kg/m²]
Mean (Standard Deviation)
 25.87  (2.33) 
Creatinine Clearance 
[Units: mL/min/1.73 m²]
Mean (Standard Deviation)
 86.60  (14.85) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)   [ Time Frame: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose ]

2.  Primary:   Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum   [ Time Frame: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose. ]

3.  Secondary:   Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)   [ Time Frame: Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01639222     History of Changes
Other Study ID Numbers: CW-2200-401-RD
2011-005786-21 ( EudraCT Number )
U1111-1124-2328 ( Registry Identifier: WHO )
First Submitted: July 9, 2012
First Posted: July 12, 2012
Results First Submitted: March 25, 2013
Results First Posted: October 18, 2013
Last Update Posted: October 18, 2013