Trial reportAnnals of the rheumatic diseases2005
A randomised, placebo controlled, comparative trial of the gastrointestinal safety and efficacy of AZD3582 versus naproxen in osteoarthritis.
Trial report in Annals of the rheumatic diseases, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 105 citations in OpenAlex.
- Effects of Analgesics on Self-Reported Physical Function and Walking Ability in People With Hip or Knee Osteoarthritis: A Systematic Review and Meta-Analysis.Physical therapy · 2024Pooled it
- Modelling of pain intensity and informative dropout in a dental pain model after naproxcinod, naproxen and placebo administration.British journal of clinical pharmacology · 2011Trial
- Greater reduction of knee than hip pain in osteoarthritis treated with naproxen, as evaluated by WOMAC and SF-36.Annals of the rheumatic diseases · 2006Trial
- Evaluating adverse events reported for non-steroidal anti-inflammatory drugs in osteoarthritis: a real-world pharmacovigilance study.Inflammopharmacology · 2026Article
- Exploiting the 2-(1,3,4,9-tetrahydropyrano[3,4-Journal of medicinal chemistry · 2025Article
- The Triple Crown: NO, CO, and HPharmacology & therapeutics · 2023Review
- Can Medical Cannabis Therapies be Cost-Effective in the Non-Surgical Management of Chronic Knee Pain?Clinical medicine insights. Arthritis and musculoskeletal disorders · 2021Article
- Gaseous Mediators as a Key Molecular Targets for the Development of Gastrointestinal-Safe Anti-Inflammatory Pharmacology.Frontiers in pharmacology · 2021Review
- Non-steroidal anti-inflammatory drugs (NSAIDs) and organ damage: A current perspective.Biochemical pharmacology · 2020Review
- Potential Strategies in the Prevention of Nonsteroidal Anti-inflammatory Drugs-Associated Adverse Effects in the Lower Gastrointestinal Tract.Gut and liver · 2020Review
- Protective Effects ofEvidence-based complementary and alternative medicine : eCAM · 2020Article
- Nitric oxide in the gastrointestinal tract: opportunities for drug development.British journal of pharmacology · 2019Review
- The dichotomous role of HBiochemical pharmacology · 2018Review
- Gaseous Mediators in Gastrointestinal Mucosal Defense and Injury.Digestive diseases and sciences · 2017Review
- Mechanisms, prevention and clinical implications of nonsteroidal anti-inflammatory drug-enteropathy.World journal of gastroenterology · 2013Review
- Efficacy and tolerability of naproxen/esomeprazole magnesium tablets compared with non-specific NSAIDs and COX-2 inhibitors: a systematic review and network analyses.Open access rheumatology : research and reviews · 2013Article
- Common secondary causes of resistant hypertension and rational for treatment.International journal of hypertension · 2011Article
- Treatment strategies for osteoarthritis patients with pain and hypertension.Therapeutic advances in musculoskeletal disease · 2010Article
- Chemopreventive efficacy of naproxen and nitric oxide-naproxen in rodent models of colon, urinary bladder, and mammary cancers.Cancer prevention research (Philadelphia, Pa.) · 2009Article
- Role of nitric oxide in the gastrointestinal tract.Arthritis research & therapy · 2008Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 7 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the gastrointestinal safety and efficacy of the COX inhibiting nitric oxide donator AZD3582 in patients with hip or knee osteoarthritis.
methods970 patients were randomised (7:7:2) to AZD3582 750 mg twice daily, naproxen 500 mg twice daily, or placebo twice daily in a double blind study. The primary end point was the six week incidence of endoscopic gastroduodenal ulcers (diameter > or =3 mm). Overall damage measured on the Lanza scale was a secondary end point. Safety and tolerability assessments included endoscopic upper gastrointestinal erosions and the gastrointestinal symptom rating scale (GSRS). Efficacy was primarily assessed by WOMAC.
resultsThe incidence of ulcers with AZD3582 was 9.7% and with naproxen 13.7% (p = 0.07, NS), v 0% on placebo. The incidence of Lanza scores >2 was higher with naproxen (43.7%) than with AZD3582 (32.2%) (p<0.001). Compared with baseline, significantly fewer ulcers and erosions developed in stomach and stomach/duodenum combined, and fewer erosions developed in stomach, duodenum, and both combined on AZD3582 than on naproxen. GSRS reflux and abdominal pain subscale scores were lower for AZD3582 than for naproxen but there was no difference for indigestion, constipation, and diarrhoea. AZD3582 was as effective as naproxen at improving WOMAC scores. Both agents were well tolerated, with no significant effects on blood pressure.
conclusionsAt doses with similar efficacy in relieving osteoarthritis symptoms, the primary end point of six week endoscopic gastroduodenal ulcer incidence was not significantly different between AZD3582 and naproxen. Most secondary endoscopic gastrointestinal end points favoured AZD3582.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.