Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547559
Recruitment Status : Unknown
Verified October 2014 by Xinxin Huang, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2012
Last Update Posted : October 21, 2014
Information provided by (Responsible Party):
Xinxin Huang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Non-steroidal Anti-inflammatory Drug Adverse Reaction Drug: part1:teprenone Drug: part1:EAC-T Drug: part1:EA-EMC-T Drug: part2:GGA group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs
Study Start Date : June 2007
Estimated Primary Completion Date : November 2014

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 Name: teprenone 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 Name: 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 Name: 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 positive patients.
Other Name: 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 Name: GGA

No Intervention: part2:control group
diclofenac sodium only for patients with rheumatic diseases

Primary Outcome Measures :
  1. part1:the total proportion of peptic ulcers after treatment [ Time Frame: 12 weeks ]
  2. part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. part1:the development of gastroduodenal ulcers [ Time Frame: 12 weeks ]
  2. part1:the healing rate of gastroduodenal ulcers [ Time Frame: 12 weeks ]
  3. part1:the improvement of erosions [ Time Frame: 12 weeks ]
  4. part2:capsule endoscopy (CE) Lewis Score after treatment [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547559

China, Guangdong
the first Affiliated Hospital of Sun Yat-Sen university
Guang zhou, Guangdong, China, 510008
the first Affiliated Hospital of Sun Yat-Sen university
Guang zhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Study Chair: Minhu Chen, MD PHD First Affiliated Hospital, Sun Yat-Sen University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xinxin Huang, doctor, Sun Yat-sen University Identifier: NCT01547559     History of Changes
Other Study ID Numbers: 5010-2007005
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Antineoplastic Agents