Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis

NCT01201122 | Completed Phase 4 DMC

• 1 other identifier: 0052-10-WOMC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa compared with twice daily in children with mild to moderate active ulcerative colitis.

Conditions

Mild to Moderate Ulcerative Colitis

Keywords

Pediatric; Ulcerative colitis; 5-ASA; Mesalamine; Dosing

Outcome Measures

Primary Outcomes (1)

• Difference in mean PUCAI score between the groups.

  At week 6 after initiation of therapy.

Secondary Outcomes (1)

• Treatment success defined as Complete response OR large partial response.

  At 3 and 6 weeks from initiation of therapy.

Study Arms (2)

Weight based Mesalamine: Once daily

EXPERIMENTAL

Drug: Mesalamine

Weight based Mesalamine: Twice daily

EXPERIMENTAL

Drug: Mesalamine

Interventions

Mesalamine DRUG

Dosing: The current standard of care for pediatric UC is 75mg/kg/day of mesalamine (Pentasa) and should be in multiplications of 500mg (half sachets). Patients will be randomized in blocks of six stratified by weight groups: 15- \<30 kg, 30-40kg, \>40kg. For body wt. 15- \<20kg Arm: Once daily, 1000 mg (morning) and Placebo (0.5 sachet) (evening). Arm: Twice daily, 500mg (morning) and 500mg (evening). For body wt: 20- \<30 kg Arm: Once daily, 1500mg (morning) and Placebo (0.5 sachet) (evening). Arm: Twice daily, 1000mg (morning) and 500mg (evening). For Body wt. 30- \<40 kg Arm: Once daily, 2000mg (morning) and Placebo (1 sachet) (evening). Arm: Twice daily, 1000mg (morning) and 1000mg (evening). For body wt. ≥40 kg Arm: Once daily, 3000mg (morning) and Placebo (1.5 sachet) (evening). Arm: Twice daily, 1500mg (morning) and 1500mg (evening).

Weight based Mesalamine: Once daily; Weight based Mesalamine: Twice daily

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children 6-18 years of age, weight least 15kg.
• Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
• Mild to moderate disease activity at the time of enrolment as judged by the Pediatric UC Activity Index (PUCAI) score 10-55 points.
• In general good health (other than the diagnosis of UC), based on medical history, physical examination, and screening laboratory results.
• Infectious colitis excluded by stool cultures, ova and parasite examination and Clostridium difficile assay.
• Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent.

You may not qualify if:

• Weight \<15 kg at enrolment
• Patients whose disease is confined to the rectum (i.e. proctitis).
• Fever \>38.5 degrees.
• Patients with Crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
• Treatment with oral 5-ASA oral preparation with at least 50mg/kg/day \> 3 days within 7 days prior to screening visit. Patients who are treated with 5-ASA \<50mg/kg/d may be enrolled as their dose will be increased significantly in this trial. A sensitivity analysis is planned including only 5-ASA naïve children.
• Exacerbation associated with infectious organism in the stool.
• Current treatment with steroids (any dose) or the need for steroid therapy as judged by the responsible gastroenterologist.
• Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the dose and frequency has remained stable during the previous 30 days prior to the screening visit. No changes are allowed after randomization and until completion of the study.
• Treatment with immunomodulatory therapy including, but not limited to: 6 mercaptopurine (6-MP), azathioprine, cyclosporine, tacrolimus, rosiglitazone or methotrexate, is allowed if the dose and frequency has remained stable during the previous 90 days prior to the screening visit. No changes are allowed after randomization and until completion of the study.
• Treatment with biologic therapy including, but not limited to: infliximab, certolizumab, adalimumab within 90 days prior to screening visit.
• Pregnancy. All female patients of childbearing potential will undergo urine pregnancy testing at screening, must not be lactating, and willing to use acceptable contraception if sexually active.
• Known allergy to 5ASA, salicylates, or aminosalicylates.
• Existence of current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is \> 1.5 times the upper limit of the age appropriate normal.
• Existence of current hepatic disease, or liver tests (ALT, AST, T-Bili) that are \> 2 times the upper limit of normal, or the existence of Primary Sclerosing Cholangitis (PSC).
• History of recurrent pancreatitis.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Arie Levine, MD

  Pediatric Gastroenterology and Nutrition Unit, The E. Wolfsom MC, Tel-Aviv Universiy, Holon, Israel

  STUDY CHAIR

• Dan Turner, MD, PhD

  Pediatric Gastroenterology and Nutrition Unit, The Hebrew Universitiy of Jerusalem, Shaare Zedek MC, Jerusalem, Israel

  STUDY DIRECTOR

• Ron Shaoul, MD

  Pediatric Gastroenterology Unit, Meyer Children's Hospital, Rambam MC, Haifa, Israel

  PRINCIPAL INVESTIGATOR

• Batia Weiss, MD

  Safra Children's Hospital, Sheba MC, Tel-Hashomer, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Gastroenterology and Nutrition Unit

Study Record Dates

• First Submitted: September 12, 2010
• First Posted: September 14, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

IL (1)