Phase 4
Completed N=75
Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)
Source: ClinicalTrials.gov NCT00686543 ↗Enrolled (actual)
75
Serious AEs
20.6%
Results posted
May 2010
Primary outcomePrimary: Mean POS Plasma Concentrations on Days 2, 3, and 8. — 230; 346; 637 ng/mL
Summary
The purpose of this study is: to explore the potential for different dosing strategies of posaconazole oral suspension (POS) to increase plasma levels and to profile the pharmacokinetics of these dosing strategies in patients with compromised gastrointestinal function and at high risk for Invasive Fungal Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean POS Plasma Concentrations on Days 2, 3, and 8. |
230; 346; 637 | — |
| PRIMARY Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen |
620; 849; 473; 660; 930; 671 | — |
| PRIMARY Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8 |
17; 2; 19; 8; 22; 30 | — |
| PRIMARY Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8 |
25; 3; 28; 7; 14; 21 | — |
| PRIMARY Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15 |
3; 3; 3; 2; 0; 1 | — |
| PRIMARY Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15 |
5; 3; 5; 1; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects >=18 years of age
- High risk of poor enteral medication absorption, based on the effects of cytotoxic chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and diarrhea, at baseline.
- High risk of invasive fungal infection (IFI) based on anticipated or documented prolonged neutropenia (absolute neutrophil count [ANC] 2 prior to induction chemotherapy for their underlying disease.
- Subjects with proven or probable invasive or systemic fungal infection at Baseline.
- Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.
Data sourced from ClinicalTrials.gov (NCT00686543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.