High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

NCT00495521 | Terminated Phase 2 Results

• 1 other identifier: PASER - AFC.002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Conditions

Crohn's Disease

Keywords

Crohn's; Crohn's Disease; Acute Flare; Mild to Moderate Crohn's Disease; Children; Pediatrics; Ileo-cecal; Pediatric Crohn's Disease; New Onset Crohn's Disease; Recently diagnosed Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline

  Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of \>70 points by 4 weeks after randomization compared with baseline

  4 weeks

Secondary Outcomes (12)

• Rate of Remission

  4 weeks

• Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks

  4 weeks

• Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks

  4 weeks

• Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary

  up to 4 weeks

• Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks

  4 weeks

Study Arms (2)

Active

EXPERIMENTAL

4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks

Drug: 4-Aminosalicylic acid extended release granules

Placebo

PLACEBO COMPARATOR

Placebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks

Drug: 4-Aminosalicylic acid extended release granules

Interventions

4-Aminosalicylic acid extended release granules DRUG

Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm

Also known as: PASER® Granules (or Placebo Granules), 4-Aminosalicylic acid, NDC 49938-107-04, 4-ASA

Active; Placebo

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age less than 18 years
• Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
• Harvey Bradshaw Index of at least 7
• The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
• Written informed consent

You may not qualify if:

• Concomitant corticosteroids, budesonide
• Corticosteroids within 2 months
• Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
• Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
• If the severity of the flare has started to decrease spontaneously
• Coexisting diagnosis of primary sclerosing cholangitis
• Infectious diarrhea
• Signs of intestinal obstruction or perforation
• New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare
• Hypersensitivity to 4-ASA or any components of PASER®
• Pregnancy or breast-feeding
• Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active
• Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC \< 3,000 during the preceding three months

Sponsors & Collaborators

• Jacobus Pharmaceutical: lead

Study Sites (5)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, San Francisco

San Francisco, California, 94143-0316, United States

Location

Children's Center for Digestive HealthCare, LLC

Atlanta, Georgia, 30342, United States

Location

Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital

Morristown, New Jersey, 07962, United States

Location

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Crohn Disease; Pediatric Crohn's disease

Interventions

Aminosalicylic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Kathy Aleš, Medical Director
• Organization: Jacobus Pharmaceutical Company, Inc.

kathy.ales@jacobus-pharmaceutical.com

609-921-7448

Study Officials

• David P Jacobus, MD

  Jacobus Pharmaceutical

  STUDY CHAIR

• Kathy L Ales, MD

  Jacobus Pharmaceutical

  STUDY DIRECTOR

• George D Ferry, MD

  Texas Children's Hospital, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Marla C Dubinsky, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Joel R Rosh, MD

  Atlantic Health System, Morristown General Hospital, Goryeb Children's Hospital

  PRINCIPAL INVESTIGATOR

• Melvin B. Heyman, M.D., M.P.H.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Stanley A. Cohen, M.D.

  Children's Center for Digestive Healthcare, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 21, 2017
• Results First Posted: September 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)