Research for Prevention and Treatment of NSAIDs Related G... | NCT01547559

Studies
Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

NCT01547559

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Oct 21, 2014Estimated

Enrollment

369Actual

Phase

Not Applicable

Conditions

Non-steroidal Anti-inflammatory Drug Adverse Reaction

Interventions

part1:teprenone
part1:EAC-T
part1:EA-EMC-T
part1:teprenone
part2:GGA group

Countries

China

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

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Nov 2014Estimated

Completion Date

Not provided

First Submitted Date

Mar 7, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 8, 2012Estimated

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

Oct 20, 2014

Last Update Posted Date

Oct 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

We aim to evaluate the protective effects of eradication of HP and continue using Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions. We further aim to explore the effect of GGA on small-intestinal mucosal injuries induced by diclofenac sodium in patients with rheumatic diseases who didn't take NSAIDs in the preceding 6 months.

Detailed Description

NSAIDs are mainly used drugs in rheumatic disease and cardiologic disease. However the gastroenterological lesions prevent patients get benefits from continuing taking NSAIDs. HP is another important factor that increase gastroenterological lesions. Both HP and NSAIDs increase risk of peptic ulcers, however, no exact relation between these two factors has been found. It is important to evaluate the protective effects of eradication of HP in NSAIDs-taking patients. In many countries ,PPI is recommended as maintain treatment in NSAIDs-taking patients to prevent gastroenterological lesions. A multicenter, open-label, randomized, parallel-group study is needed to prove the effects of Teprenone as a replacer of PPI in maintain treatment.On the other hand, Small-intestinal mucosal injuries induced by non-steroidal anti-inflammatory drugs (NSAIDs) are common. However, there are still no effective and reliable interventions established. Geranylgeranylacetone (GGA) is a mucosal protective agent, so we develop an additional trail to clarify the discrepancies of GGA effects on NSAIDs-induced small-intestinal mucosal injuries.

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

369Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
part1:blank control	No Intervention	NO maintain drugs with Hp negative patients.
part1:teprenone 1	Experimental	maintain treatment with Teprenone for Hp negative patients	Drug: part1:teprenone
part1:EAC-T	Experimental	eradication of Hp with triple treatment	Drug: part1:EAC-T
part1：EA-EMC-T	Experimental	eradication of Hp with sequential therapy	Drug: part1:EA-EMC-T
part1：T-T	Active Comparator	Teprenone as maintain drugs for Hp positive patients	Drug: part1:teprenone
part2:GGA group	Experimental	Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases

Interventions

Name	Type	Description	Arm Group Labels	Other Names
part1:teprenone	Drug	Teprenone 50mg tid after meal for Hp negative patients.	part1:teprenone 1

Measure	Description	Time Frame
part1:the total proportion of peptic ulcers after treatment		12 weeks
part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment		12 weeks

Measure	Description	Time Frame
part1:the development of gastroduodenal ulcers		12 weeks
part1:the healing rate of gastroduodenal ulcers		12 weeks
part1:the improvement of erosions

Eligibility Module

Eligibility Criteria

part1:

Inclusion Criteria:

informed consents be given before treatment
NSAIDs taking patients
not taking PPI or other digestive drugs during previous 1 months
age ranging from 18～80 years old

Exclusion Criteria:

having any severe acute or chronic complications
renal dysfunction, blood creatinine≥150µmol/L
blood aminotransferase level rising up(more than 2 times of the normal level)
any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
chronic or acute pancreatic disease
severe systematic diseases or malignant tumor
allergic to the drugs using in the trial
any factors interfering the result
female patients incline to be pregnant
being treated with drugs influencing gastroenterological conditions.
poor compliance part2:

Inclusion Criteria:

1.18 to 65 years of age 2.patients with rheumatic diseases such as ankylosing spondylitis , rheumatoid arthritis and undifferentiated arthritis 3.planning to take diclofenac sodium for at least 12 weeks 4.having freely been given their fully informed consent based on their full understanding

Exclusion Criteria:

Patients were excluded if they had a history of peptic ulcer or gastrointestinal bleeding
had serious liver, kidney, heart, or lung disease
had suspected small-bowel obstruction
had a history of gastrointestinal surgery except for appendectomy
had a drug addiction or alcoholism; were pregnant or hoped to become pregnant during the study period
were taking anti-secretory drugs such as PPIs or H2 receptor antagonists (H2RA), or other gastric mucosal protective drugs
had a lack of consent to the surgery required if the capsule endoscope was retained in the body
were judged to be inappropriate for this study by the investigator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Minhu Chen, MD PHD	First Affiliated Hospital, Sun Yat-Sen University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
the first Affiliated Hospital of Sun Yat-Sen university		Guangzhou	Guangdong	510008	China
the first Affiliated Hospital of Sun Yat-Sen university

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25660821	Derived	Xiong L, Huang X, Li L, Yang X, Liang L, Zhan Z, Ye Y, Chen M. Geranylgeranylacetone protects against small-intestinal injuries induced by diclofenac in patients with rheumatic diseases: a prospective randomized study. Dig Liver Dis. 2015 Apr;47(4):280-4. doi: 10.1016/j.dld.2015.01.005. Epub 2015 Jan 20.