Condition category
Digestive System
Date applied
13/02/2008
Date assigned
10/03/2008
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 trial’s 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 crohn’s 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

Sponsor information

Organisation

Ferring SA (France)

Sponsor details

7 rue Jean Baptiste Clément
Gentilly
94250
France

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes