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

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

4-Aminosalicylic acid

PASER placebo granules

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Acute Flare, Mild to moderate Crohn's Disease, Ileocecal distribution

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active
Severe renal or hepatic disease

Sites / Locations

The University of Chicago
Mount Sinai School of Medicine IBD Research Center
Charlotte Gastroenterology and Hepatology, PLLC
Rambam Medical Center
Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks

Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks

Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary

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

The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary

Absence of night time stools, if they were present on entry, and time to disappearance

Time to normalization of all other components in the diary

Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization

Change in global physician assessment of disease activity from baseline to study completion

Full Information

NCT ID

NCT00417690

First Posted

January 2, 2007

Last Updated

October 14, 2008

Sponsor

Jacobus Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00417690

Brief Title

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

Official Title

A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Terminated

Why Stopped

Efforts at recruitment have halted as recruitment was poor.

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Jacobus Pharmaceutical

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

4-Aminosalicylic acid

Other Intervention Name(s)

PASER Granules, NDC 49938-107-04

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PASER placebo granules

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Title

Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks

Time Frame

4 weeks

Title

Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks

Time Frame

4 weeks

Title

Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary

Time Frame

up to 4 weeks

Title

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

Time Frame

4 weeks

Title

The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary

Time Frame

up to 4 weeks

Title

Absence of night time stools, if they were present on entry, and time to disappearance

Time Frame

up to 4 weeks

Title

Time to normalization of all other components in the diary

Time Frame

up to 4 weeks

Title

Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization

Time Frame

2 weeks and 4 weeks

Title

Change in global physician assessment of disease activity from baseline to study completion

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active Severe renal or hepatic disease

Overall Study Officials: