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Completed

NCT Number: NCT01353144

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.

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chung-Ho Hospital, Kaohsiung, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

aspirin, 100 mg, qd x 8 weeks

Other names: aspirin protect

Primary outcomes

  1. Number of Participants in Whom Peptic Ulcer Was Healed

    Time frame: 8 weeks

    Number of participants in whom peptic ulcer was healed at week 8

Secondary outcomes

  1. Number of Participants Deveoping Peptic Ulcer Bleeding

    Time frame: 8 weeks

    Number of participants deveoping peptic ulcer bleeding during 8-week study period

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 12, 2011
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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