Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| compounded ternary parenteral nutrition | Active Comparator | compounded ternary Parenteral Nutrition admixture |
|
| Oliclinomel N4 formulation | Experimental | Oliclinomel N4 is a ready-to-use PN product presented as a triple chamber bag |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oliclinomel N4 | Other | Oliclinomel is a PN product which provides the macronutrients (e.g., dextrose, amino acids, and lipids) for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Prealbumin | Serum Prealbumin at Day 5 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Baxter Investigative Site | Shanghai, China | Study Director |
| Baxter Investigative Site | Shantou, China | Study Director |
| Baxter Investigative Site | Haikou, China | Study Director |
| Baxter Investigative Site | Jiangsu Province, China | Study Director |
| Baxter Investigative Site | Beijing, China | Study Director |
| Baxter Investigative Site | Changsha, China | Study Director |
| Baxter Investigative Site | Hangzhou, China | Study Director |
| Baxter Investigative Site | Nanning, China | Study Director |
| Baxter Investigative Site | Shang dong Province, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai No. 6 Hospital | Shanghai | China |
Not provided
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Compounded ternary parenteral nutrition admixtures | Other | Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days |
|