- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277223
Curcumin in Pediatric Ulcerative Colitis
Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Petach Tikva, Israel, 4259000
- Schneider Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
- Age: 6 - 18 years (inclusive).
- PUCAI 10-65 at enrollment
- Negative stool culture, parasites and clostridium toxin
- 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.
Exclusion Criteria:
- Acute severe UC (PUCAI>65 points) requiring IV corticosteroids.
- History of two relapses or more on 5-ASA treatment.
- Pregnancy
- Sepsis or active bacterial infection
- Fever >38.5 degrees.
- Patients whose disease is confined to the rectum (i.e. proctitis).
- Patients with crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
- Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the dose and frequency has remained stable during the previous 14 days prior to the screening visit.
- Known allergy to 5ASA, salicylates, or aminosalicylates.
- History of recurrent pancreatitis.
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Interventional
In addition to induction therapy, patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight<20kg: 1 gram, twice daily, 20-30 kg: 1.5 grams twice daily, weight>30kg: 2 grams twice daily.
For Maintenance, in addition to oral 5-ASA maintenance treatment, responding patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight<30kg: 500 milligram, twice daily, weight>30kg: 1 gram twice daily
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Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses. Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin.
Other Names:
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Placebo Comparator: Control
In addition to induction and maintenance therapy, patients will receive matched oral placebo capsules for induction and maintenance (Bara Herbs Inc), twice daily.
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Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses. Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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A change in disease activity, defined by PUCAI at 2 weeks and 6 months
Time Frame: 6 months
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sustained clinical remission, 2 weeks and 6 months
Time Frame: 6 months
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6 months
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Medication associated adverse events
Time Frame: 6 months
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6 months
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Time to relapse
Time Frame: 6 months
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6 months
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The need for further medical interventions (e.g topical 5-ASA) during the maintenance phase
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Amit Assa, MD, Schneider Children's Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- PUCC 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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