A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000612-54-SE

Enrollment

1360

Registered

2004-07-07

Start date

2004-09-11

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161 Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037

Interventions

Product Name: L-001069957 Product Code: L-001069957 Pharmaceutical Form: Tablet INN or Proposed INN: 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Greater than or equal to 45 years of age, clinical diagnosis of OA or RA, prior history of therapuetic benefit from non-steroidal anti-inflammatory or COX-2 inhibitory medications, free of gastric and/or duodenal ulcers at the time of randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Gastric and/or duodenal ulcers at the time of randomization, positive occult blood on stool Hemoccult testing, erosive esophagitis =2 American College of Rheumatology (ACR) functional class IV, uncontrolled diabetes, uncontrolled hypertension, angina (unstable or at rest), congestive heart failure, confounding medical condition, significant findings on screening physical examination and/or laboratory results

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the comparative cumulative incidence of gastric and/or duodenal ulcers (3 = mm) following administration over 12 weeks of L-001069957 21 mg plus EC aspirin 100 mg once daily, L-001069957 42 mg plus EC aspirin 100 mg once daily, celecoxib 200 mg twice daily plus EC aspirin 100 mg once daily and EC aspirin 100 mg daily.;Secondary Objective: To assess the general safety and tolerability of L-001069957 21 mg plus EC aspirin 100 mg once daily and L-001069957 42 mg plus EC aspirin 100 mg once daily.;Primary end point(s): Development of gastric and/or duodenal ulcers	—

Measure

Time frame

Main Objective: To determine the comparative cumulative incidence of gastric and/or duodenal ulcers (3 = mm) following administration over 12 weeks of L-001069957 21 mg plus EC aspirin 100 mg once daily, L-001069957 42 mg plus EC aspirin 100 mg once daily, celecoxib 200 mg twice daily plus EC aspirin 100 mg once daily and EC aspirin 100 mg daily.;Secondary Objective: To assess the general safety and tolerability of L-001069957 21 mg plus EC aspirin 100 mg once daily and L-001069957 42 mg plus EC aspirin 100 mg once daily.;Primary end point(s): Development of gastric and/or duodenal ulcers

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026