Contact information
Type
Scientific
Primary contact
Prof Jean Pierre Cezard
ORCID ID
Contact details
Hopital Robert Debré 48 Bd Sérurier
Paris
75019
France
+33 (0)1 40 03 23 62
jean-pierre.cezard@rdb.aphp.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Etude Pentacomp/90/91
Study information
Scientific title
Prevention of relapse by mesalazine (Pentasa®) in paediatric crohn's disease: a multicentric double-blind randomised placebo-controlled trial
Acronym
Study hypothesis
The trials primary objective was to compare the efficacy of mesalazine (Pentasa®, Ferring) versus placebo in maintaining remission in paediatric crohn's disease (CD) patients, when used after the successful treatment of an acute episode with either medication alone or parenteral/enteral nutrition techniques combined or not with medication.
Ethics approval
Ethcis approval received from the Ethics Committee of Paris VII on the 10th January 1991 (ref: Etude Pentacomp/90/01).
Study design
A multicentric, double-blind, randomised, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Paediatric crohn's disease
Intervention
At inclusion, patients were randomised per stratum, within each centre, using random permuted two to four sized-blocks (each centre did not know the size of their own block), to the following:
1. 50 mg/kg/day mesalazine dose
2. Placebo (identical tablets)
This was taken over a one-year period. Patients were monitored every three months over a one-year period or until endpoint.
The study treatment was initiated either one week after the interruption of parenteral or enteral nutrition, or at the end of a sulfalazine or metronidazole treatment, or if the prednisone dose during the steroid weaning period was below 0.2 mg/kg. After the study treatment began, only antispasmodic and antidiarrhoeal agents, as well as sedatives were to be given as possible additional medications.
Following the recruitment of 57 children from 1991 to 1993, trial results showed a trend favouring mesalazine. Recruitment was consequently resumed from 1996 to 1999.
Intervention type
Drug
Phase
Not Specified
Drug names
Mesalazine (Pentasa®)
Primary outcome measures
1. Clinical relapse (HB score greater than or equal to 5, if confirmed within two weeks)
2. Surgery for an acute complication of CD
Primary and secondary outcomes were measured either at one year of follow up with a medical visit every three months or when the primary or secondary outcomes occur during the one year follow up.
Secondary outcome measures
Treatment failure, defined as:
1. Relapse
2. Failure of steroid withdrawal (weaning failure)
3. Side-effects intolerance requiring treatment discontinuation
4. Worsening or aggravation of patient status requiring treatment interruption
5. Initiation of a new treatment as decided by the clinician
Primary and secondary outcomes were measured either at one year of follow up with a medical visit every three months or when the primary or secondary outcomes occur during the one year follow up.
Overall trial start date
01/01/1991
Overall trial end date
01/01/1998
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children less than 18 years old, either sex
2. Diagnosed with crohns disease before the age of 16 by means of clinical, radiological, endoscopic and histological data
3. Had to be in an active phase defined by:
3.1. A Harvey Bradshaw score (HB) greater than or equal to 5, and
3.2. An erythrocyte sedimentation rate (ESR) greater than or equal to 25 mm at hour one
4. All lesion localisations, except exclusive anorectal localisation, were included, providing patients lesion extension had been assessed within two years prior to inclusion
After flare-up treatment, inclusion criteria were as follows:
1. Patients in clinical remission within six months following flare-up treatment initiation at pre-inclusion
2. An HB score under 5
3. An ESR under 25 mm
4. Normal hepatic and renal functions
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60, extended to 120
Participant exclusion criteria
1. Flare-up had been treated with mesalazine or had required immuno-suppressors
2. Patients with known hypersensitivity to salicylate
3. Patients whose flare-up had occurred at pre-inclusion when on a 5-aminosalicylic acid (5-ASA) dose greater than 50 mg/kg/day for over two months
Recruitment start date
01/01/1991
Recruitment end date
01/01/1998
Locations
Countries of recruitment
France, Switzerland
Trial participating centre
Hopital Robert Debré 48 Bd Sérurier
Paris
75019
France
Funders
Funder type
Industry
Funder name
Ferring SA (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary