A RANDOMIZED DOUBLE-BLIND PARALLELL GROUP CLINICAL STUDY OF XENETIX 300 VERSUS VISIPAQUE 270 IN MULTISLICE CT PEDIATRIC INDICATIONS - PEDIATRIC MSCT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000664-51-AT

Enrollment

142

Registered

2005-11-22

Start date

2005-12-27

Completion date

Unknown

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients requiring MSCT with contrast medium injection for diagnosis

Interventions

Trade Name: XENETIX 300 MG I / ML Product Name: XENETIX 300 MG I / ML Pharmaceutical Form: Solution for injection INN or Proposed INN: IOBITRIDOL Concentration unit: mg/ml milligram(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Child aged between 1 and 16 years, having an MSCT with contrast product injection planned - Patient planned for a blood test in the 24 hours preceding the scan - Female patient with child bearing potential with contracetion or who has a negative BetaHCG test - Parents (and the child if aged over 12 years) having given their consent to participate in the study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients who has received diuretic or biguanide treatment during 48 hours preceding the MSCT - Patients having received an iodinated contrast agent during the 48 hours preceding the MSCT

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the equivalence of Xenetix 300 and Visipaque 270 in terms of renal tolerance when injected for MSCT in pediatric indications;Secondary Objective: To compare the two agents in terms of clinical safety and global imaging efficacy in pediatric MSCT;Primary end point(s): Calculation and assessment of the creatinine clearance according to Schwartz's formula, within 24 hours before the contrast medium administration and 72 +/- 12 hours after the contrast medium administration	—

Measure

Time frame

Main Objective: To demonstrate the equivalence of Xenetix 300 and Visipaque 270 in terms of renal tolerance when injected for MSCT in pediatric indications;Secondary Objective: To compare the two agents in terms of clinical safety and global imaging efficacy in pediatric MSCT;Primary end point(s): Calculation and assessment of the creatinine clearance according to Schwartz's formula, within 24 hours before the contrast medium administration and 72 +/- 12 hours after the contrast medium administration

—

Countries

Austria, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026