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OpenTrials
Completed

NCT Number: NCT01190657

Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

This is a self-controlled, open, multiple-center clinical trial.

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Key information

Conditions

Acute Gastritis Digestive System Diseases Duodenal Diseases Gastric Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese People's Liberation Army General Hospital of Beijing Military, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age is over 18 years old , men or women
  • Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;
  • Signed the informed consent forms.

Exclusion criteria

  • Patients without inclusion criteria
  • Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease
  • Patients with other digestive diseases.
  • Patients with operation on stomach and duodenum.
  • Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids
  • Patients with severity trauma, surgery, infection and shock.
  • Patients with any kind of tumor
  • Women either pregnant or breast feeding

Treatment and study plan

Selbex

Drug

50mg/day, 3 times/day, for 14 days

Primary outcomes

  1. Endoscopic results of ulcer lesion

    Time frame: 56 days

    Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %

  2. Total effective rate

    Time frame: 56 days.

    Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.

Secondary outcomes

  1. Symptoms improved level

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2010
Registry last updated
Apr 1, 2013

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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