Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2015
Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03176121 (A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain), which is not on this map. Cited by 24 papers.
What it found
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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.
A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain
Who cites it
24 citing papers in PubMed, 67 citations in OpenAlex.
- Long-term efficacy and safety of oxycodone-naloxone prolonged-release formulation (up to 180/90 mg daily) - results of the open-label extension phase of a phase III multicenter, multiple-dose, randomized, controlled study.European journal of pain (London, England) · 2017Trial
- High dosage of a fixed combination oxycodone/naloxone prolonged release: efficacy and tolerability in patients with chronic cancer pain.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Trial
- Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment.Advances in therapy · 2017Trial
- Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility.Advances in therapy · 2016Trial
- Managing Severe Cancer Pain with Oxycodone/Naloxone Treatment: A Literature Review Update.Journal of personalized medicine · 2024Review
- Hydrocodone, Oxycodone, and Morphine Metabolism and Drug-Drug Interactions.The Journal of pharmacology and experimental therapeutics · 2023Review
- No pain, no strain: Targin® mitigates pain and constipation following spinal cord injury.Annals of clinical and translational neurology · 2023Article
- CANCER PAIN AND THERAPY.Acta clinica Croatica · 2022Review
- Current management of cancer pain in Italy: Expert opinion paper.Open medicine (Warsaw, Poland) · 2022Review
- Insights into the Use of Peripherally Acting μ-Opioid Receptor Antagonists (PAMORAs) in Oncologic Patients: from Scientific Evidence to Real Clinical Practice.Current treatment options in oncology · 2021Review
- Clinical Efficacy of Controlled-Release Morphine Tablets Combined with Celecoxib in Pain Management and the Effects on WNK1 Expression.Clinics (Sao Paulo, Brazil) · 2021Article
- Prolonged-release oxycodone/naloxone reduces opioid-induced constipation and improves quality of life in laxative-refractory patients: results of an observational study.Clinical and experimental gastroenterology · 2018Article
- Oxycodone/Naloxone Prolonged Release: A Review in Severe Chronic Pain.Clinical drug investigation · 2017Review
- The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference.Alimentary pharmacology & therapeutics · 2017Article
- Naloxegol in opioid-induced constipation: a new paradigm in the treatment of a common problem.Patient preference and adherence · 2017Review
- The role of naloxegol in the management of opioid-induced bowel dysfunction.Therapeutic advances in gastroenterology · 2016Review
- Quality of life under oxycodone/naloxone, oxycodone, or morphine treatment for chronic low back pain in routine clinical practice.International journal of general medicine · 2016Article
- Switching to low-dose oral prolonged-release oxycodone/naloxone from WHO-Step I drugs in elderly patients with chronic pain at high risk of early opioid discontinuation.Clinical interventions in aging · 2016Observational
- Long-term efficacy and safety of oxycodone-naloxone prolonged release in geriatric patients with moderate-to-severe chronic noncancer pain: a 52-week open-label extension phase study.Drug design, development and therapy · 2016Observational
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate the long-term safety and efficacy of prolonged-release oxycodone/naloxone (OXN PR) and its impact on quality of life (QoL), in patients with moderate-to-severe cancer pain.
methodsThis was an open-label extension (OLE) of a 4 week, randomized, double-blind (DB) study in which patients with moderate-to-severe cancer pain had been randomized to OXN PR or oxycodone PR (OxyPR). During the OLE phase, patients were treated with OXN PR capsules (≤ 20/60 mg/day) for ≤ 24 weeks. Outcome measures included safety, efficacy and QoL.
resultsOne hundred and twenty-eight patients entered the OLE, average pain scores based on the modified Brief Pain Inventory-Short Form were low and stable over the 24-week period. The improvement in bowel function and constipation symptoms as measured by the Bowel Function Index and patient assessment of constipation in patients treated with OXN PR during the 4-week DB study was maintained. In patients treated with OxyPR during the DB phase, bowel function and constipation symptoms were improved during the OLE. In the DB and in the OLE, health status and QoL were similar for patients treated with OXN PR and OxyPR. There were no unexpected safety or tolerability issues.
conclusionsIn patients with moderate-to-severe cancer pain, long-term use of OXN PR is well tolerated and effective, resulting in sustained analgesia, improved bowel function and improved symptoms of constipation.
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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.