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Clinical study to investigate the efficacy, safety and tolerability of Naloxone in patients with opioid induced constipation.

ABSTRACT: Primary objectives: The primary objective of the trial is to demonstrate that administration of Naloxone HCl PR (prolonged-release) tablets twice daily is superior to Naloxone HCl PR Placebo in the improvement / reversal of opioid-induced constipation as determined by the bowel function index (BFI). Primary end point is defined as the absolute change in BFI score at the end of Week 12 (Visit 11) compared to baseline (Visit 4)

DISEASE(S): Opioid Induced Constipation,Opioid-induced Bowel Dysfunction (obd) Involves Not Only Constipation, But Also A Constellation Of Symptoms Including Incomplete Evacuation, Bloating, Abdominal Distension, And Increased Gastric Reflux. Constipation Is An Almost Inevitable Consequence Of Opioid Use In Malignant And Non-malignant Disease States, And One Of The Side Effects Of Opioids To Which Few Patients Develop Tolerance.

PROVIDER: 2531166 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Clinical study to investigate the efficacy, safety and tolerability of Naloxone in patients with opioid induced constipation.

Project description:Primary objectives: The primary objective of the trial is to demonstrate that administration of Naloxone HCl PR (prolonged-release) tablets once daily is superior to Naloxone HCl PR Placebo in the improvement / reversal of opioid-induced constipation (OIC) as determined by the Bowel Function Index (BFI). Primary end point is defined as the absolute change in BFI score at the end of Week 12 (Visit 11) compared to baseline (Visit 4).

| 2531364 | ecrin-mdr-crc

Efficacy of Oxycodone/Naloxone(OXN), Versus Oxycodone (OXY), for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients

Project description:The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the reduction of the intensity of opioid-induced constipation symptoms in patients treated for cancer or non-cancer pain.

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Oxycodone-naloxone in Relieving Opioid-related Constipation

Project description:The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

| 2035377 | ecrin-mdr-crc

Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Project description:The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

| 2035373 | ecrin-mdr-crc

Naloxone influences NSCs proliferation and differentiation

Project description:Naloxone is an opioid-receptor antagonist used to reverse the effects of opioid.In our study, we treated NSCs (neural stem cells) with naloxone and damgo (a selective μopioid receptor agonist), and examined their effects on NSCs proliferation and differentiation.Naloxone was found to promote NSCs proliferation and neural differentiation, while the effects of damgo was very week. The results suggested that naloxone may work indepedent of opioid receptors. To investigate the underlying mechanisms, RNA-seq was conducted. For proliferation analysis,p8 NSCs were cultured with or without naloxone or damgo for 3 days. For differentiation analysis,p8 NSCs was induced to differentiate with or without naloxone or damgo, samples on D2,4,8 were collected and analyzed.

2020-03-04 | GSE106376 | GEO

DNA methylation maps of mouse NSCs treated with naloxone

Project description:In our study,we examined the effects of naloxone (an opioid receptor antagonist) on NSCs (neural stem cells) proliferation and differenntiation. Briefly, we treated NSCs with naloxone in the proliferation and differentiation system. Naloxone was shown to acclerate NSCs proliferation and increase neural differentiation.To investigate how DNA methylation is affected upon naloxone treatment, cells cultured 3 days with naloxone and cells differentiated with naloxone at D2 were collected, genomic DNA was extracted and subjected to RRBS analysis.

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Effects of naloxone on NSC proliferation and differentiation

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Analgesia of naloxone and morphine in wild-type and NY1DD sickle cell mice using BMAP cDNA microarrays

Project description:Sickle cell disease is the most common genetic disorder in African-Americans. The opioid analgesic, morphine, has long been the treatment for the severe pain associated with this disease. Here we reveal that the opioid antagonist, naloxone, possesses potent analgesic activity in two strains of sickle cell mice (NY1DD and hBERK1) and not in their respective controls (ICR-CD1 and C57BL/6J) when administered by three parenteral routes. In the NY1DD sickle mice, naloxone (i.c.v.) possessed ~300-fold greater potency than morphine (i.c.v.). Other opioid antagonists (naltrexone, norbinaltorphimine, naltrindole) were substantially less effective in producing analgesia. Naloxone and morphine were synergistic in NY1DD mice, suggesting that analgesia was mediated via different receptor systems. Since microarray analysis suggested naloxone-induced down-regulation of the CCR5 chemokine receptor in NY1DD mice but not in control mice, the role of its endogenous ligand, CCL5 (RANTES), was investigated. Keywords: Comparison of drug induced gene expression

2007-12-20 | GSE6479 | GEO

Analgesia of naloxone in wild-type and NY1DD transgenic mouse model of sickle cell anemia using BMAP cDNA microarrays

2007-03-14 | GSE6578 | GEO

Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain

Project description:RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine. PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.

| 2006458 | ecrin-mdr-crc

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