STA-5326 in Crohn's Disease Patients

A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00088062

Enrollment

Registered

2004-07-21

Start date

2004-02-29

Completion date

2004-11-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Brief summary

The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.

Interventions

DRUGSTA-5326

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients 18-65 years old * Crohn's Disease for 6 months * CDAI scores between 220-450 * +/- 5-ASA, stable dose for \> 2 weeks * +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks * +/- Infliximab with no treatment within 4 weeks * +/- 6-Mercaptopurine, with a stable dose for 8 weeks * +/- Antibiotics, with a stable dose for 2 weeks

Exclusion criteria

* Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening * Pregnancy, breast feeding * History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study * Bowel obstruction * Surgical bowel resection within 90 days * Total parenteral nutrition (TPN), CYA, tacrolimus

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026