Trial reportClinical rheumatology2017
Low-dose SoluMatrix diclofenac in patients with osteoarthritis pain: impact on quality of life in a controlled trial.
Trial report in Clinical rheumatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 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
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.
- Benefits of Applying Nanotechnologies to Hydrogels in Efficacy Tests in Osteoarthritis Models-A Systematic Review of Preclinical Studies.International journal of molecular sciences · 2022Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Low-dose SoluMatrix diclofenac was developed to provide effective pain relief for osteoarthritis pain. We evaluated the effects of SoluMatrix diclofenac on health-related quality of life (HRQoL) measures in patients with osteoarthritis, hypothesizing that SoluMatrix-treated patients would experience significant improvement compared with placebo. In this 12-week, phase 3 randomized controlled trial, 305 patients with osteoarthritis of the hip or knee received SoluMatrix diclofenac 35 mg three times (TID) or twice (BID) daily or placebo. Measures included HRQoL, assessed by Short Form 36 (SF-36, version 2), and pain, stiffness, and physical function, assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and at week 12. Descriptive statistics were calculated for mean changes from baseline; inferential statistics compared treatment groups with placebo. SoluMatrix diclofenac 35 mg BID (6.2 [0.75]; P = 0.0048) or TID (6.6 [0.80]; P = 0.0014) produced large improvements in the SF-36 physical component summary (PCS) scores at week 12 (least squares mean change from baseline [SE]) compared with placebo (3.5 [0.78]). Minimum clinically important differences were observed in six out of eight SF-36 domains among patients in SoluMatrix diclofenac groups and five out of eight domains in the placebo group; treatment with SoluMatrix diclofenac 35 mg TID produced significant improvements (P ≤ 0.03) in five out of eight domains versus placebo. SoluMatrix diclofenac 35 mg TID significantly improved responses to 23 out of 24 questions in the WOMAC versus placebo (P ≤ 0.0334). Low-dose SoluMatrix diclofenac 35 mg TID and BID significantly improved HRQoL, pain, stiffness, and physical function in patients with osteoarthritis of the hip or knee.
Indexed as
Identifiers
What OpenQuestion holds
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.