Sponsor:Nycomed Imaging ASOslo, Norway

Reference no.3 NycomedAirershom

ReportDXC060

CLINICAL STIJDY REPORT

\¡rsrpAQuEr gooxaxoL) rN PAEDTATRICGASTROINTESTINAL EXAIVÍINATIONS

A multicentre randomizf,narallel group, doubleblind phase rrr comparisonbetween iodix¡¡or (wslpAe^m6¡ tso mg vmr

"t a szo mg vmi

and iohexol (Omnipaque"¡ 140 mg Umt and 300 mg Vml

Principal investigator: prof. Eeren carty, Alder Eey children,s Hospital

Study Initiation Date: 23 April 1997Study Completion Dete: 13 August l99gReport Completion Date: 4 June 1999

the "EEC Guidelines on Good Clinical practicean Community'', July 1990. For the reporting

has been adopted. consolidated Guideline" approved uyìtre tcH

NycomedAÉrershom

Pegc 2 of45

2 SYNOPSIS

Namc of Sponror/Company:Nycomed lmaging AS

Individu¡l Study Tablc Referringto Pert of Do¡sicr i¡ lYhich theIndividurl Study or Study Teblei¡ Prcscntcd

Volume:

Refercnce:

(For National Authority Useonly)

Name of Fi¡ished Product:ov¡slpaque

ODIXANOL) IN PAEDTATRIC GASTROINTESTINAL EXAÀ{INATIONS

Investigator(s): Prof. Helen Carty, Dr. Neville W.ig¡t, Dr. Alan Sprigg, Dr. Merete Friis, Dr. Karin KastbergPete¡sen, Dr. Gtmnar Stake

Study centre(s):Alder Hev ChildrerÌ'Royal Manchester C ster, UKShefüeld Child¡cr¡'sBooth Hall Child¡e¡r's Hospital, Manchester, IJKGlostrup Amtssygehus, Copenhager¡ D€:DmarkSkejby' Sygehus, fut¡us, De¡ma¡k

Evaluation: None

Publication (rcference): Not

Studv period:23 April 1997 -

To evaluate and compare 9"...ffi*ty.-a safety of vtsnAeuEols0 mg l/ml and 320 mg uml to omnipaqueo140 mg Vnrl a¡rd 300 me Vml in oaediatric netientc nndroninc ââ#^:-rd:-^r v __. ____: - ^.

Methodology:

).

tance".

NycomedAmershom

Pegc 3 of45

Neme of Spousor/Company:Nycomed Imaging AS

Individu¡I Study Table Referringto Pert of Dossier in IVhich theIndividurl Study or Study Teblei¡ Prcsented

Volume:

Reference:

(For National Authority Useonly)

Nrue of Finished Product:6v¡s¡Paque

uice.

Diagnosis and main criteri¡ for inclusion:Pa.ediltng in' and out'patient¡ (0 - <16 years of age) referred for upper or lower gastrointestinal examinationsusing iodinated cont¡ast media

retion, batch nurnben320 mg VmI administered oraly @y drirking, by a qringe, by aor ostomy or rectally. Dose normally 5-50 ñ1, for follow-th¡ough

Batch numbers;

VIStrAQUE9 (iodixanol) 150 mg ymt 6il076, exp. dare I l-99320 mg Vrnl 6041 69, exp. date 05-99

Duratiou of treatment: The patients were included into the tial the day before or the same day asafrer the X-ray o<amination.

Refereuce thò*0,*" ;ffiï:lïl,ï'", drinkins by a syringe, by a

::Hf"Hr or rectally. oo." noáary 5_5ó mr, roi øríñ_tr,rough

Batch numbe¡s:

omlgaqli@ (iohexol) 140^mg yml 603153, exp. date l0-99 and FFgl/098-703, exp. date 04-99 (The latrer forpal Nos. 0010155-00 l0¡ 60).

300 ms Vml 5l I

Criteria for evaluatio¡ :

dAom

examination a¡rd ar crinicar 0.," "r*il**t lHt#iË,n*'H".il::on obtained, based on the X-rav

only one appointed investigator in eech tial ccntre wss performing the eficary evalu¿tjons.

_ .

NycomedAmershom

Prge 4 of45

Name of Sponsor/Compeny:Nycomed Imaging AS

I¡dividud Study Table Referringto P¡rl of Do¡rier in Which theIndþidud Study or Study Tablei¡ Presented

Volume:

Refe¡ence:

(For National Authority Useonly)

N¡ne of Fi¡isbed P¡oduct:Visipaqueo

Jh-e quality of radiographic visualiz¿tion provided in the contast-e,ntranced images was rated accord.ing to the

followin g four categories :

No visualization of contrast medium in the region of interestInsuf¡cient radiographic visu¿rization. Inferiór radiographic delineationSr¡fücie¡t radiographic visuarization. Adequaûe radiogaphic deri¡eationsuperior radiographic vizualization. Vcry detailed radiographic deliseation

The overall evaluations (of radiographic visualization and diapostic inforruation) were obtained on VAS(Visual Analogue Scale).The degree of_contrast opaciûcation was evaluated as too high, optimal or too low deruity or none.The coating of mucosa was scored in categories poor, good and excellent.

Safetv:The patients were closely obse¡ved for any kind of adverse event during the trial procedures and up to 2 daysafrer the last administration of the investigational d*gs (by telçhone fõltow-up¡.

Other safety vari ables:

Brqnghial asPiration upon intake of the cont¡ast med.ium was recorded in the CRF (answered with.]es,'or"no").Taste acceDtance was evaluated using the categories'good", "accçtable", ..unpleasant"

and..bad,,.

Statistical methods:The mainAnarogue il##.i:åä.ffi,IË:ïH"overall an sis claimed a diference to Uî prLnt.ADANOVA (analysis'of-variance) was performed in o the meao scores. The associated 95%

confider¡ce interr¡al for lhe difference in mean score w¿ìs calculated.A comparison of t¡ste accÆpta¡ce was made by a Fisher's Exact-test The null hypot¡esis stated no difereocebetween tl¡e contrast medig-

NycomedAmershom

Name of Sponror/Company:N¡-comed Irnaging AS

Individual Study Table ReferrÍngto P¡rt of Dossier iu Which theI¡dividurl Study or Study Tabteir Prerentcd

Volume:

Rcfercnce:

(For National Authority Useonly)

N¡nc of Finished Produc't:6v$rpaque

SUMMARY_ CONCLUSIONS:

EFFICACY RESULTS:No diference between the two contrast Eedium groups was obse¡ved, regard.ing the efficacy variables evaluatedin this rial.

SAFETY RESULTS:

owe to thosePati patientsthe iohexol

Thrce patiens had some kind of skin reaction afrer the q(amination, all belonging in the iodixanol group. Bronchialaspiration occurred for one patient in cach goup.

No serious adverse event was rçorted dr:ring the conduct of this tial.

There were no adverse events leading to changes i¡ dose or administration procedrue, nor any events resulting inwiùdrawal from the u-ial. Four patients had eveas that gave r€¡¡son for medical ¡'eatnert,

Taste acceptance: In total" 33 patiørs scored tbe taste as good, 36 æ acceptabl¿, I 9 as unpleasanla¡d 16 as óad..No

statistically sip,ifcant differerice between the contas media was pr"Lt G=O.55). Taste was uot evaluatedb¡- -18 of the patients receiving conEast mediuûI.

CONCLUSION:

f the gastrointestinal tract in children. The effcacyiodixanol a¡rd iohexol. Fewer adverse weots wcre

rül€nc€ ofdiarrhoea). Taste acceptance was goodfor

Date of the final rcport: 4 June 1999