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NCT00977964 · ClinicalTrials.gov registry record · Phase 3
Tolerance of Healthy Term Infants Fed Infant Formulas #3
A Phase 3 study of Gastrointestinal Tolerance, sponsored by Abbott Nutrition.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
- 15
- Study locations
NCT00977964: Completed Phase 3 study of Gastrointestinal Tolerance, sponsored by Abbott Nutrition.
NCT00977964 is a Phase 3 study of Gastrointestinal Tolerance that has completed, run by Abbott Nutrition. The registered enrollment target is 270 participants, above the 140-participant average among 4 other Gastrointestinal Tolerance trials with a reported enrollment target (93% higher). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00977964, a Phase 3 study of Gastrointestinal Tolerance, has completed, sponsored by Abbott Nutrition.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
- 15
- Study locations
Study Summary
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
Conditions Studied
Interventions
- OTHER Experimental milk protein infant formula Process A
- OTHER Experimental milk protein infant formula Process B
- OTHER Experimental milk protein infant formula Process C
- OTHER Experimental milk protein infant formula Process D
- OTHER Experimental milk protein infant formula Process E
Study Locations (15)
Ohio
- Pediatric Associates of Mount Carmel, Inc - Cincinnati
- MetroHealth Medical Center - Cleveland
- Dayton Clinical Research - Dayton
- Ohio Pediatric Research Association, Inc. - Huber Heights
- Institute of Clinical Research - Mayfield Heights
Florida
- All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc - Plantation
- SCORE Physician Alliance, LLC - St. Petersburg
- University of South Florida - Tampa
Alabama
- Alabama Clinical Therapeutics - Dothan
Georgia
- North Georgia Clinical Research - Dalton
Indiana
- Northpoint Pediatrics, LLC - Indianapolis
Iowa
- Medical Associates Clinic, PC - Dubuque
Kentucky
- Kentucky Pediatric / Adult Research - Bardstown
Tennessee
- The Jackson Clinic, PA - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00977964 record still lists
NCT00977964 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, above the 140-participant average among 4 other Gastrointestinal Tolerance trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Gastrointestinal Tolerance appearing as the primary indexed condition, and to 5 interventions - of which Experimental milk protein infant formula Process A is the first listed.
NCT00977964 lists 15 locations in 9 states (Ohio, Florida, Alabama).
Frequently Asked Questions
What is clinical trial NCT00977964 about?
NCT00977964 is a clinical study titled "Tolerance of Healthy Term Infants Fed Infant Formulas #3". The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
What is the current status of trial NCT00977964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2009-09. Estimated completion is 2010-01.
What conditions does trial NCT00977964 study?
This clinical trial studies the following conditions: Gastrointestinal Tolerance.
What interventions are being tested in trial NCT00977964?
The interventions under investigation include: Experimental milk protein infant formula Process A (OTHER), Experimental milk protein infant formula Process B (OTHER), Experimental milk protein infant formula Process C (OTHER), Experimental milk protein infant formula Process D (OTHER), Experimental milk protein infant formula Process E (OTHER).
Who is sponsoring clinical trial NCT00977964?
This trial is sponsored by Abbott Nutrition, which has 89 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00977964 being conducted?
This trial has 15 study locations across Alabama, Florida, Georgia, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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