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NCT01216293 · ClinicalTrials.gov registry record · Phase 1
Effect of Dexlansoprazole on Bone Homeostasis
A Phase 1 study of Bone and Bones and Homeostasis, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
- 12
- Study locations
NCT01216293: Completed Phase 1 study of Bone and Bones and Homeostasis, sponsored by Takeda.
NCT01216293 is a Phase 1 study of Bone and Bones and Homeostasis that has completed, run by Takeda. The registered enrollment target is 115 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01216293, a Phase 1 study of Bone and Bones and Homeostasis, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Esomeprazole
- DRUG Dexlansoprazole
Study Locations (12)
California
- - San Diego
- - Walnut Creek
Florida
- - Hialeah
- - Jupiter
Texas
- - Austin
- - San Antonio
Colorado
- - Lakewood
Maryland
- - Bethesda
New Mexico
- - Albuquerque
South Carolina
- - Spartanburg
Washington
- - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2010-11-01 |
| Est. Completion | 2015-02-01 |
| Phase | Phase 1 |
What the finished NCT01216293 record still lists
NCT01216293 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% higher).
The record links to 2 conditions, with Bone and Bones appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01216293 lists 12 locations in 9 states (California, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT01216293 about?
NCT01216293 is a clinical study titled "Effect of Dexlansoprazole on Bone Homeostasis". The purpose of this study is to evaluate the effect of dexlansoprazole modified release (MR), once daily (QD), on bone homeostasis.
What is the current status of trial NCT01216293?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2010-11-01. Estimated completion is 2015-02-01.
What conditions does trial NCT01216293 study?
This clinical trial studies the following conditions: Bone and Bones, Homeostasis.
What interventions are being tested in trial NCT01216293?
The interventions under investigation include: Placebo (DRUG), Esomeprazole (DRUG), Dexlansoprazole (DRUG).
Who is sponsoring clinical trial NCT01216293?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01216293 being conducted?
This trial has 12 study locations across California, Colorado, Florida, Maryland, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bone and Bones
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01216293's enrollment target sits among peer trials
115 504th of 2000 higher than 1,494 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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