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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.

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