A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2007-005702-49-PL
• Date of registration: 17/06/2009
• Prospective Registration: Yes
• Primary sponsor: Procter & Gamble Pharmaceuticals
• Public title: A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II
• Scientific title: A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005702-49
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Poland

Key inclusion & exclusion criteria

Inclusion criteria:
Patients are eligible to participate in the study if they:
a. are male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication, with a history of biopsy and endoscopy confirmed UC;
b. have mildly-to-moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score = 10 and = 55, and, in the opinion of the Investigator, the patient does not require steroids
c. have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1-2 stools greater than normal per day) as defined by the TM-Mayo Score
d. are generally in good health (other than the diagnosis of UC), based on medical history, physical examination, and screening laboratory results;
e. are able to swallow Asacol tablets (400 mg marketed US formulation);
f. have a body weight no less than 17 kg and no more than 90 kg;
g. are female patients who are pre-menarchal or have a negative urine pregnancy test and, if sexually active, practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy). All female patients of childbearing potential will undergo urine pregnancy testing at Screening and must not be lactating; and
h. are able and willing to participate in the study and follow study procedures, as evidenced by the child providing assent and the parent/guardian signing a written informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients will be excluded from admission to the study if they:
a. have a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any
component of the Asacol tablet;
b. have a history or presence of any condition causing malabsorption or an effect on
gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome;
c. are current abuser of drugs or alcohol;
d. have a history of HIV infection or AIDS;
e. have a significant co-existing illness or other condition(s), including but not limited to cancer or significant organic or psychiatric disease on medical history or physical examination, that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedures;
f. have 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;
g. have a documented history of or current hepatic disease, or liver function tests (ALT, AST, T Bili) that are > 2 times the upper limit of normal;
h. have a history of pancreatitis;
i. have any other screening laboratory test values that the Investigator or Sponsor considers clinically significant that would impact the outcome of the study or the safety of the patient;
j. previously participated in this study;
k. participated in any other drug or device clinical study within 30 days prior to the Screening visit;
l. are currently participating in any other clinical study;
m. have undergone treatment with any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days prior to the Screening visit;
n. have undergone treatment with any other topical (non-oral) mesalamine therapy within 7 days prior to the Screening visit;
o. have undergone treatment with immunomodulatory therapy including, but not limited to: rosiglitazone, 6-mercaptopurine or azathioprine, cyclosporine, or methotrexate within 90 days prior to Screening visit;
p. have undergone treatment with biologic therapy including, but not limited to: infliximab, certolizumab, adalimumab or other biologic treatment of UC within 90 days prior to Screening visit;
q. have undergone treatment with antibiotics (other than topical antibiotics) including
metronidazole within 7 days prior to the Screening visit;
r. have undergone treatment with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days prior to the Screening visit;
s. have undergone treatment with any antidiarrheals and/or antispasmodics within 3 days of the Screening visit; or
t. have a stool examination positive for Clostridium difficile (C. difficile), bacterial pathogens, or ova and parasites.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents
MedDRA version: 11.0 Level: LLT Classification code 10045365 Term:

Intervention(s)

Trade Name: Asacol
Product Name: Asacol
Product Code: NA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MESALAZINE
CAS Number: 89576
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 0.4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is the proportion of patients that achieve PUCAI-TS

Main Objective: The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed-release tablets given every 12 hours for 6 weeks to children and adolescents with mildly-to-moderately active ulcerative colitis.
The primary efficacy objective is to assess the proportion of patients that achieve treatment success using the validated Pediatric Ulcerative Colitis Activity Index (PUCAI).

Secondary Objective: The secondary efficacy objectives are to assess the following:
• PUCAI Complete Response;
• PUCAI Partial Response;
• PUCAI Treatment Failure;
• Truncated Mayo Treatment Success;
• Truncated Mayo Complete Response;
• Truncated Mayo Partial Response;
• Truncated Mayo Treatment Failure.
To assess biomarker resolution in Asacol treated pediatric patients with mildly-to-moderately active UC, secondary objectives will include assessment of biomarker endpoints as follows:
• the proportion of patients who show reduction from Baseline in the fecal and serum
lactoferrin and calprotectin biomarkers;
• the proportion of patients who achieve a specified cutoff level in fecal lactoferrin and calprotectin biomarkers;
• the change in lactoferrin and calprotectin biomarkers from Baseline to Week 6.

Secondary ID(s)

2007017