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Completed

NCT Number: NCT00392080

A Study Of The Effect Of CJ-023,423 On The Incidence Of Stomach Ulcers

CJ-023,423 is a new medication being developed as an anti-inflammatory agent for the treatment of the signs and symptoms of osteoarthritis (OA). The purpose of this study is to evaluate whether patients treated with CJ-023,423 for 7 days (14 doses) have fewer gastrointestinal ulcers compared to patients treated with naproxen and placebo.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests
  • If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug;

Exclusion criteria

  • Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0);
  • Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery;

Treatment and study plan

CJ-023,423

Drug

75 mg BID

Placebo

Drug

placebo

Naproxen

Drug

naproxen

Primary outcomes

  1. The primary endpoint is the presence of gastroduodenal ulcers in each subject, as determined by a UGI endoscopy at the end of the treatment

    Time frame: 7 days

Secondary outcomes

  1. Incidence of treatment-emergent, all-causality GI body system adverse events

    Time frame: Duration of trial

  2. Severity of Dyspepsia Assessment (SODA)

    Time frame: Duration of trial

  3. Post treatment gastric, duodenal and gastroduodenal endoscopic scores (according to the mucosal grading scale). The gastroduodenal score is defined as the higher of the gastric and duodenal scores.

    Time frame: Duration of trial

  4. Incidence of any gastric ulcer

    Time frame: Duration of trial

  5. Incidence of any duodenal ulcer

    Time frame: Duration of trial

  6. Incidence of any gastroduodenal erosion or ulcer

    Time frame: Duration of trial

  7. Incidence of any gastric erosion or ulcer

    Time frame: Duration of trial

  8. Incidence of any duodenal erosion or ulcer

    Time frame: Duration of trial

  9. Incidence of any esophageal ulcer using the traditional grading method of: normal, erosion or ulcer

    Time frame: Duration of trial

  10. Incidence of any esophageal ulcer or erosion using the LA classification: esophageal ulcers and erosions method with a Grade A, B, C, or D)

    Time frame: Duration of trial

  11. Number of gastroduodenal ulcers in each subject

    Time frame: Duration of trial

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects

Important dates

Study start
2006
Study completion
2008
First posted
Oct 25, 2006
Registry last updated
Mar 24, 2008

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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