Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorSynta Pharmaceuticals Corp.
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450 
NCT00088062
Principal SponsorSynta Pharmaceuticals Corp.
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

Advanced Clinical Therapeutics

Tucson, United StatesSee the location
Suspended

Advanced Clinical Research Institute

Anaheim, United States
Suspended

Venture Research Institute, LLC

North Miami Beach, United States
Suspended

Shafran Gastoenterology Center

Winter Park, United States
Completed18 Study Centers