Aminosalicylic Acid Withdrawal Study in Long Standing Ina... | NCT02537210

Studies
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

NCT02537210

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

May 31, 2023Actual

Enrollment

177Actual

Phase

Not Applicable

Conditions

Colitis, Ulcerative
Aminosalicylic Acid

Interventions

Mesalazine
Placebo oral capsule

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Sep 10, 2021Actual

Completion Date

Sep 10, 2021Actual

First Submitted Date

Aug 28, 2015

First Submission Date that Met QC Criteria

Aug 29, 2015

First Posted Date

Sep 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2023

Last Update Posted Date

May 31, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Siew Chien NG, Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Name	Class
Queen Elizabeth Hospital, Hong Kong	OTHER
Alice Ho Miu Ling Nethersole Hospital	OTHER
Tseung Kwan O Hospital, Hong Kong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Detailed Description

This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

177Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesalazine	Active Comparator	mesalazine 2g od po for 12 months	Drug: Mesalazine
Placebo oral capsule	Placebo Comparator	placebo 5 capsules od po for 12 months	Drug: Placebo oral capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesalazine	Drug	Patients will be prescribed Asacol 2g daily for 12 months	Mesalazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The differences of relapse rates between the two arms	Relapse rate of patient in both arms will be calculated	12 months

Secondary Outcomes

Measure	Description	Time Frame
Patients' drug compliance	Proportion of patients with good drug compliance, defined as more than 80% of drug taken will be evaluated.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
in long-standing clinical remission
written informed consent

Exclusion Criteria:

allergic to mesalazine
prior bowel surgery except appendectomy
hepatic or renal dysfunction
malignant disease within 5 years
pregnancy or breast feeding or women of child-bearing age without regular use of contraception
on anti-tumor necrosis factor therapy
terminal illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Siew Ng, PhD	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Hong Kong		0000	Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019804	Mesalamine

Ancestor Terms

ID	Term
D062368	meta-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided