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A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01353144
First received: May 11, 2011
Last updated: September 12, 2016
Last verified: September 2016

May 11, 2011
September 12, 2016
June 2007
May 2008   (final data collection date for primary outcome measure)
Number of Participants in Whom Peptic Ulcer Was Healed [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Number of participants in whom peptic ulcer was healed at week 8
Rate of Ulcer Healing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
ulcer healing rate at week 8
Complete list of historical versions of study NCT01353144 on ClinicalTrials.gov Archive Site
Number of Participants Deveoping Peptic Ulcer Bleeding [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Number of participants deveoping peptic ulcer bleeding during 8-week study period
Rate of Peptic Ulcer Bleeding [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
rate of peptic ulcer bleeding within 8-week study period
Not Provided
Not Provided
 
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.

Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peptic Ulcer
Drug: aspirin
aspirin, 100 mg, qd x 8 weeks
Other Name: aspirin protect
  • No Intervention: esomeprazole
    esomeprazole (40 mg/day) for 8 weeks
  • Active Comparator: esomeprazole plus aspirin
    esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
    Intervention: Drug: aspirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • aspirin users who have a peptic ulcer confirmed by endoscopy

Exclusion Criteria:

  • serious medical illness (including cardiovascular events within 6 months before endoscopy)
  • acute gastrointestinal bleeding
  • a history of gastric or duodenal surgery
  • allergic to the study drugs
  • require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents
  • pregnancy
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01353144
VGHKS96-CT4-26
Yes
Not Provided
Not Provided
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital.
Not Provided
Study Chair: Kwok-Hung Lai, MD Kaohsiung Veterans General Hospital.
Kaohsiung Veterans General Hospital.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP