Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

October 20, 2014 updated by: Xinxin Huang, Sun Yat-sen University

Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

369

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guang zhou, Guangdong, China, 510008
        • The First Affiliated Hospital of Sun Yat-Sen University
      • Guang zhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

part1:

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: part1:blank control
NO maintain drugs with Hp negative patients.
Experimental: part1:teprenone 1
maintain treatment with Teprenone for Hp negative patients
Drug: part1:teprenone
Teprenone 50mg tid after meal for Hp negative patients.
Other Names:
  • teprenone treatment
Drug: part1:teprenone
Teprenone 50mg tid after meal for Hp positive patients.
Other Names:
  • T-T treatment
Experimental: part1:EAC-T
eradication of Hp with triple treatment
Drug: part1:EAC-T
esomeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily followed by gastric mucosal protective therapy with teprenone 50mg three times daily for 11 weeks
Other Names:
  • EAC-T treatment
Experimental: part1：EA-EMC-T
eradication of Hp with sequential therapy
Drug: part1:EA-EMC-T
esomeprazole 20 mg plus amoxicillin 1 g, twice daily for 5 days, then esomeprazole 20 mg with clarithromycin 500 mg and metronidazole 500 mg, twice daily for another 5 consecutive days) followed by teprenone 50mg three times daily until 12 weeks
Other Names:
  • EA-EMC-T treatment
Active Comparator: part1：T-T
Teprenone as maintain drugs for Hp positive patients
Drug: part1:teprenone
Teprenone 50mg tid after meal for Hp negative patients.
Other Names:
  • teprenone treatment
Drug: part1:teprenone
Teprenone 50mg tid after meal for Hp positive patients.
Other Names:
  • T-T treatment
Experimental: part2:GGA group
Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases
Drug: part2:GGA group
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
Other Names:
  • GGA
No Intervention: part2:control group
diclofenac sodium only for patients with rheumatic diseases

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
part1:the development of gastroduodenal ulcers
Time Frame: 12 weeks
12 weeks
part1:the healing rate of gastroduodenal ulcers
Time Frame: 12 weeks
12 weeks
part1:the improvement of erosions
Time Frame: 12 weeks
12 weeks
part2：capsule endoscopy (CE) Lewis Score after treatment
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Minhu Chen, MD PHD, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

March 7, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5010-2007005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-steroidal Anti-inflammatory Drug Adverse Reaction

Clinical Trials on part1:teprenone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe