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Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Xinxin Huang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01547559
First received: March 7, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to investigate and evaluate the protective effects of eradication of HP and continue using teprenone on NSAIDs related gastroenterological lesions.


Condition Intervention
Non-steroidal Anti-inflammatory Drug Adverse Reaction
 Drug: teprenone
Drug: EAC-T
Drug: EA-EMC-T

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • the total proportion of peptic ulcers after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the development of gastroduodenal ulcers [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • the healing rate of gastroduodenal ulcers [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • the improvement of erosions [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 369
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: blank control
NO maintain drugs with Hp negative patients.
Experimental: teprenone 1
maintain treatment with Teprenone for Hp negative patients
 Drug: teprenone
Teprenone 50mg tid after meal for Hp negative patients.
Other Name: teprenone treatment
Experimental: EAC-T
eradication of Hp with triple treatment
 Drug: 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 Name: EAC-T treatment
Experimental: EA-EMC-T
eradication of Hp with sequential therapy
 Drug: 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 Name: EA-EMC-T treatment
Active Comparator: T-T
Teprenone as maintain drugs for Hp positive patients
 Drug: teprenone
Teprenone 50mg tid after meal for Hp positive patients.
Other Name: T-T 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547559

Locations
China, Guang dong
the first Affiliated Hospital of Sun Yat-Sen university
Guang zhou, Guang dong, China, 510008
China, Guangdong
the first Affiliated Hospital of Sun Yat-Sen university
Guang zhou, Guangdong, China, 510008
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Minhu Chen, MD PHD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Xinxin Huang, doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01547559     History of Changes
Other Study ID Numbers: 5010-2007005
Study First Received: March 7, 2012
Last Updated: March 13, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Drug Toxicity
Poisoning
Substance-Related Disorders
Anti-Inflammatory Agents, Non-Steroidal
Geranylgeranylacetone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013