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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00038766 |
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Date of registration:
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05/06/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
CD02 |
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Scientific title:
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A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease |
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Date of first enrolment:
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June 2002 |
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Target sample size:
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33 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00038766 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Daan Hommes, M |
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Address:
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Telephone:
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Email:
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Affiliation:
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Academic Medical Center, Netherlands |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive
- Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis,
confirmed by radiography and/or endoscopy
- Patients receiving medications for CD must be on stable doses entering the study
- Any CD medication which has been discontinued must have been discontinued at least 4
weeks prior to screening, with the exception of infliximab, which must have been
discontinued at least 8 weeks prior to screening
Exclusion Criteria
- Patients with any ostomy or extensive bowel resection
- Current evidence of bowel obstruction or history within the preceding six months as
confirmed by radiography, endoscopy, or surgery
- Patients with stool examination positive for enteric pathogens, pathogenic ova or
parasites, or Clostridium difficile toxin
- Treatment with any other experimental therapeutics within the last 4 weeks before
enrollment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: placebo
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Drug: semapimod
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Primary Outcome(s)
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Change in CDAI
[Time Frame: Day 29]
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Secondary Outcome(s)
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Change in IBDQ
[Time Frame: Day 29]
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Secondary ID(s)
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CNI-1493 CD-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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