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

NCT00417690 | Terminated Phase 2

• 1 other identifier: PASER-AFC.001
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• 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 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Acute Flare; Mild to moderate Crohn's Disease; Ileocecal distribution

Outcome Measures

Primary Outcomes (1)

• Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline

  4 weeks

Secondary Outcomes (10)

• Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks

  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

• Increase in IBDQ to greater than 170 and the time to score above 170

  4 weeks

Study Arms (2)

A

EXPERIMENTAL

Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks

Drug: 4-Aminosalicylic acid

P

PLACEBO COMPARATOR

One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks

Drug: PASER placebo granules

Interventions

4-Aminosalicylic acid DRUG

Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks

Also known as: PASER Granules, NDC 49938-107-04

A

PASER placebo granules DRUG

Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks

P

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Crohn's disease involving predominantly 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, including budesonide
• Corticosteroids within the previous 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
• Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
• If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months
• Current experimental drugs or experimental drugs within the last 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 or abscess,
• New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare,
• Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare
• Allergy or sensitivity to salicylates
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Jacobus Pharmaceutical: lead

Study Sites (5)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Mount Sinai School of Medicine IBD Research Center

New York, New York, 10028, United States

Location

Charlotte Gastroenterology and Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Crohn 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

Study Officials

• David P. Jacobus, MD

  Jacobus Pharmaceutical

  STUDY CHAIR

• Kathy L. Ales, MD

  Jacobus Pharmaceutical

  STUDY DIRECTOR

• Daniel Present, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Stephen B. Hanauer, MD

  University of Chicago Hospitals

  PRINCIPAL INVESTIGATOR

• John Hanson, MD

  Charlotte Gastroenterology & Hepatology, PLLC

  PRINCIPAL INVESTIGATOR

• Iris Dotan, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

• Rami Eliakim, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 4, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: October 1, 2008
• Last Updated: October 15, 2008

Record last verified: 2008-10

Locations

US (3); IL (2)