|
Welcome
|
|
02 September 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
|
Efficacy of mesalazine to prevent relapse in paediatric crohn’s disease
|
| ISRCTN | ISRCTN84003996 |
| ClinicalTrials.gov identifier | |
| Public title |
Efficacy of mesalazine to prevent relapse in paediatric crohn’s disease
|
| Scientific title | Prevention of relapse by mesalazine (Pentasa®) in paediatric crohn's disease: a multicentric double-blind randomised placebo-controlled trial |
| Acronym | N/A |
| Serial number at source | Etude Pentacomp/90/91 |
| 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 |
| Countries of recruitment | France, Switzerland |
| Disease/condition/study domain | Paediatric crohn's disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/1991 |
| Anticipated end date | 01/01/1998 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 60, extended to 120 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding | Ferring SA (France) |
| Trial website | |
| Publications | |
| Contact name | Prof Jean Pierre Cezard |
| Address | Hopital Robert Debré 48 Bd Sérurier |
| City/town | Paris |
| Zip/Postcode | 75019 |
| Country | France |
| Tel | +33 (0)1 40 03 23 62 |
| Fax | +33 (0)1 40 03 57 66 |
| jean-pierre.cezard@rdb.aphp.fr | |
| Sponsor | Ferring SA (France) |
| Address | 7 rue Jean Baptiste Clément |
| City/town | Gentilly |
| Zip/Postcode | 94250 |
| Country | France |
| Date applied | 13/02/2008 |
| Last edited | 10/03/2008 |
| Date ISRCTN assigned | 10/03/2008 |
|
|
|
|
|
| © 2010 ISRCTN unless otherwise stated. | |
|
|
|
|