NCT03220841

Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: St Vincent's Hospital Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Detailed description

Prospective randomised controlled study. Patients with Crohn's Disease who have symptomatic inflammatory intestinal strictures will be randomised to receive standard drug therapy (Anti-TNF monotherapy at standard dose) or intensive drug therapy (Intense Anti-TNF dose induction and escalation for continued inflammation in combination with thiopurine) for 12 months.

Conditions

• Crohn Disease
• Inflammatory Bowel Diseases
• Stricture; Bowel

Interventions

Type	Name	Description
DRUG	Adalimumab Injection	Standard dose adalimumab induction and maintenance
DRUG	Thiopurine	Dose optimized thiopurine
PROCEDURE	Endoscopic balloon dilatation	Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.

Timeline

• Start date: 2017-10-09
• Primary completion: 2020-09-18
• Completion: 2021-09-01
• First posted: 2017-07-18
• Last updated: 2020-10-23

Locations

1 site across 1 country: Australia