A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

NCT00175032 | Completed Phase 3

• 2 other identifiers: LAN-0003-0041U1111-1114-2275
• Study Type: interventional
• Target: 1,045
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.

Conditions

Osteoarthritis; Peptic Ulcer

Keywords

Low dose aspirin; Peptic Ulcer; gastric ulcer; duodenal ulcer; NSAIDs

Outcome Measures

Primary Outcomes (1)

• Gastroduodenal ulcers at final visit

  Week 12

Secondary Outcomes (6)

• Proportion of subjects with GI complications (GI bleeding, perforation and gastric outlet obstruction)

  Week 12

• Severity of each dyspepsia symptom (abdominal pain, nausea, vomiting, heartburn, fullness, and belching) and combined dyspepsia scores.

  Weeks 4,8, and 12

• Proportion of subjects with dyspepsia at weeks 4, 8, and 12 that did not have dyspepsia at baseline.

  Weeks 4,8, and 12

• Proportion of subjects without dyspepsia at weeks 4, 8, and 12 who had dyspepsia at baseline.

  Weeks 4, 8, and 12

• Scores of each SODA scale (pain intensity, non-pain symptoms, and satisfaction) for subjects with dyspepsia.

  Weeks 4, 8, and 12

Study Arms (2)

Lansoprazole 30 mg QD + Naproxen 500 mg BID

EXPERIMENTAL

(and added aspirin)

Drug: Lansoprazole and naproxen and aspirin

Celecoxib 200 mg QD

ACTIVE COMPARATOR

(and added aspirin)

Drug: Celecoxib and aspirin

Interventions

Lansoprazole and naproxen and aspirin DRUG

Lansoprazole 30 mg, capsules, orally once daily; Naproxen 500 mg, capsules, orally, twice daily; and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.

Lansoprazole 30 mg QD + Naproxen 500 mg BID

Celecoxib and aspirin DRUG

Celecoxib 200 mg, capsules, orally once daily and aspirin 81 mg or 325 mg, tablets, orally, once daily for up to 12 weeks.

Celecoxib 200 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must require the chronic use of a non-steroidal anti-inflammatory drug for the treatment of osteoarthritis.
• Must be taking daily aspirin for cardiovascular prophylaxis.
• Clinical Laboratory values within normal limits for this population

You may not qualify if:

• History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
• Evidence of uncontrolled, clinically significant disease.
• History of cancer within the past 5 years.
• Presence of gastroduodenal ulcers, esophageal ulcer or \>= 10 gastroduodenal erosions during the screening endoscopy. Known history of gastroduodenal ulcer or bleeding within the past year. Esophageal stricture requiring dilatation.
• Presence of Barrett's esophagus with dysplastic changes.
• Systemic disease affecting the esophagus or a history of caustic or physiochemical trauma or irradiation to the esophagus.
• Sero-tests positive for H. pylori.
• Evidence of Zollinger-Ellison syndrome, esophageal varices, cholecystitis, or pancreaticobiliary tract disease.
• Requires treatment with an excluded medication such as proton pump inhibitors, histamine H2 receptor antagonists, antacids, corticosteroids, lithium, fluconazole, misoprostol, probenecid, methotrexate, anticoagulants, St. John's wart, dong quai, feverfew, garlic, ginger, horse chestnut, red clover or white willow supplements or bisphosphonates.

Sponsors & Collaborators

• Takeda: lead

Related Publications (1)

• Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74. doi: 10.1016/j.cgh.2007.06.009.

  PMID: 17916545 RESULT

MeSH Terms

Conditions

Osteoarthritis; Peptic Ulcer; Stomach Ulcer; Duodenal Ulcer

Interventions

Lansoprazole; Naproxen; Aspirin; Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Benzenesulfonamides; Sulfonamides; Amides; Sulfones; Pyrazoles; Azoles

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: July 1, 2003
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: July 22, 2010

Record last verified: 2010-07