|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03220841 |
|
Date of registration:
|
06/07/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
STRIDENT |
|
Scientific title:
|
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study |
|
Date of first enrolment:
|
October 9, 2017 |
|
Target sample size:
|
78 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03220841 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Australia
| | | | | | | |
|
Contacts
|
|
Name:
|
Emily Wright, MBBS PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St Vincent's Hospital Melbourne |
|
|
Name:
|
Bronte Holt, MBBS PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St Vincent's Hospital Melbourne |
|
|
Name:
|
Michael Kamm, MBBS PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
St Vincent's Hospital Melbourne |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI
or endoscopy.
Exclusion Criteria:
- Acute bowel obstruction requiring urgent surgical intervention
- Deemed by treating physician to have high risk of acute bowel obstruction
- Concurrent active perianal sepsis
- Internal fistulising disease in association with strictures (entero-enteric stulas)
- Low rectal or anal strictures
- Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal
biopsies
- Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
- Inability to give informed consent
- Suspected perforation of the gastrointestinal tract
- Pregnancy
- Inability to undergo MRI small bowel due to a contraindication.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Stricture; Bowel
|
|
Crohn Disease
|
|
Inflammatory Bowel Diseases
|
|
Intervention(s)
|
|
Procedure: Endoscopic balloon dilatation
|
|
Drug: Thiopurine
|
|
Drug: Adalimumab Injection
|
|
Primary Outcome(s)
|
|
Improvement in obstructive symptoms.
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Improvement in imaging parameters (Intestinal ultrasound)
[Time Frame: 12 months]
|
|
Improvement in symptoms
[Time Frame: 4, 8 and 12 months]
|
|
Improvement in biochemical inflammatory parameters
[Time Frame: 12 months]
|
|
Improvement in imaging parameters
[Time Frame: 12 months]
|
|
Improvement in patient reported outcomes (PROs)
[Time Frame: 12 months]
|
|
Surgery
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
StVincentsMelbourneSTRIDENT1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|