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NCT00488345 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age
A Phase 2 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
NCT00488345: Completed Phase 2 study, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
NCT00488345 is a Phase 2 study that has completed, run by Wyeth is now a wholly owned subsidiary of Pfizer. The registered enrollment target is 59 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488345, a Phase 2 study, has completed, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
Study Summary
To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).
Primary Outcome
Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method. Peak concentration was taken directly from the observed data.
Interventions
- DRUG Tygacil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
What the finished NCT00488345 record still lists
NCT00488345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 1 intervention - of which Tygacil is the first listed.
NCT00488345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488345 about?
NCT00488345 is a clinical study titled "Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age". To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or c...
What is the current status of trial NCT00488345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2007-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00488345?
The interventions under investigation include: Tygacil (DRUG).
Who is sponsoring clinical trial NCT00488345?
This trial is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00488345's enrollment target sits among peer trials
59 1133rd of 2000 higher than 866 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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