The primary efficacy endpoint is treatment success in the therapy for mild to moderate Crohn*s disease with fisultas defined by: - A reduction of at least 50% in the number of draining fistulas at both week 4 and week 8
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is treatment success in the therapy for mild to
moderate Crohn*s disease with fisultas defined by: - A reduction of at least
50% in the number of draining fistulas at both week 4 and week 8
Secondary outcome
- 100% non-draining fistulas at both week 4 and week 8 (complete response)-
Absolute numbers of draining fistulas at week 4 and week 8- Change in CDAI
scores from baseline at week 4 and week 8- Change in PDAI scores from baseline
at week 4 and week 8- Time to relapse from success at week 8- Average frequency
of liquid bowel movements during the first 8 weeks- Change in CRP levels from
baseline at week 4 and week 8- Treatment failure due to the need for a change
in drug therapy needed to treat mild to moderately active Crohn*s disease at
week 4 and week 8
Background summary
Phase 3, multicenter, prospective, double-blind, randomized,
placebo-controlled, parallel group, two armed study where patients are
randomized to receive either AST-120 or placebo for 8 weeks. The proportion of
patients in each treatment arm that responds to study drug treatment will be
compared. Patients who fail the first full course (8 weeks) of randomized
treatment will have the option to receive the alternate blinded treatment for
one treatment course. Patients who do not respond to the alternate treatment
or continue to fail after 4 weeks will be discontinued from the study. Note:
Patients who do not show a reduction of at least 50% of draining fistulas until
week 8 will be considered late responders, and will not be eligible to receive
the alternate blinded treatment
Study objective
The primary efficacy endpoint is treatment success in the therapy for mild to
moderate Crohn*s disease with fisultas defined by: - A reduction of at least
50% in the number of draining fistulas at both week 4 and week 8
Study design
Phase 3, multicenter, prospective, double-blind, randomized,
placebo-controlled, parallel group, two armed study where patients are
randomized to receive either AST-120 or placebo for 8 weeks. The proportion of
patients in each treatment arm that responds to study drug treatment will be
compared. Patients who fail the first full course (8 weeks) of randomized
treatment will have the option to receive the alternate blinded treatment for
one treatment course. Patients who do not respond to the alternate treatment
or continue to fail after 4 weeks will be discontinued from the study. Note:
Patients who do not show a reduction of at least 50% of draining fistulas until
week 8 will be considered late responders, and will not be eligible to receive
the alternate blinded treatment
Intervention
3 times per day 2g AST-120 or placebo
Study burden and risks
Known side effects of AST-120 involve gastrointestinal symptoms. Constipation
was the most common adverse event overall. Abdominal pain, diarrhoea,
nausea/vomiting, rectal bleeding and feeling of a full stomach, occurred in
1-2% of the persons treated with AST-120 in previous studies.
12651 High Bluff Drive, Suite 230
CA 92130 San Diego
USA
12651 High Bluff Drive, Suite 230
CA 92130 San Diego
USA
Listed location countries
Age
Inclusion criteria
-18 to 70 years of age
-Body Weight: (>=40 kg)
-Documented diagnosis of Crohn*s disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
-Presence of at least one draining perianal fistula. Patients with enterocutaneous fistula can be included if they have >= 1 draining perianal fistula. Women with rectovaginal fistulas are included if they have >= 1 draining perianal fistula.
-Crohn*s Disease Activity Index (CDAI) score < 400
-Platelet count (thrombocytes) >= 100,000/µL
-Able and willing to comply with all protocol procedures
Exclusion criteria
Patients previously treated with infliximab for fistulas caused by Crohn*s disease and who did not respond to infliximab therapyInfliximab therapy within 3 months prior to enrollment in the studyPresence of symptomatic strictures or suggestion of significant clinical obstructionPatients with setons; unless setons are removed within 48 hours prior to study entryPresence of entero-entero, recto-vesicular, entero-vesicular fistulas§ The patient is unable to stay on a stable dose of concomitant Crohn*s disease medication(s) for at least 10 weeks in the opinion of the investigator§ Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn*s disease (e.g. bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)§ Severe diarrhea defined by > 10 liquid bowel movements per day§ Other local manifestations of mild to moderately active Crohn*s disease such as abscesses, or other disease manifestations for which surgery might be indicated, or which might preclude utilization of a CDAI to assess response to therapy (e.g. short bowel syndrome)§ Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen§ Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen§ Women who are pregnant, breast feeding, or planning to become pregnant during the study§ Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months § Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient*s ability to complete the trial§ Uncontrolled systemic disease § Patients undergoing chemotherapy for the treatment of cancer
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-005363-28-NL |
| CCMO | NL14133.078.06 |