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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000664-51-GB

Enrollment

142

Registered

2006-02-13

Start date

2006-04-26

Completion date

Unknown

Last updated

2012-03-19

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 contraception or who has a negative BetaHCG test - Parents (and child with sufficient intellectual maturity) 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 have 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
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;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	—

Measure

Time frame

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;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

—

Countries

United Kingdom

Outcome results

None listed

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