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Completed

NCT Number: NCT00088062

STA-5326 in Crohn's Disease Patients

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Advanced Clinical Therapeutics, Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STA-5326

Drug

Sponsors and collaborators

Lead sponsor

Synta Pharmaceuticals Corp.

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2004
First posted
Jul 21, 2004
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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