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Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

NCT03220841 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-10-23

No results posted yet for this study

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.

Conditions

  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Stricture; Bowel

Interventions

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.

Sponsors & Collaborators

  • Australasian Gastro Intestinal Research Foundation

    collaborator OTHER

  • AbbVie

    collaborator INDUSTRY

  • St Vincent's Hospital Melbourne

    lead OTHER

Principal Investigators

  • Emily Wright, MBBS PhD · St Vincent's Hospital Melbourne

  • Bronte Holt, MBBS PhD · St Vincent's Hospital Melbourne

  • Michael Kamm, MBBS PhD · St Vincent's Hospital Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2020-09-18
Completion
2021-09-30

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220841 on ClinicalTrials.gov