Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01438567
Brief Summary:
The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).
Detailed Description:
The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.
Study:
NCT01438567
Study Brief:
Protocol Section:
NCT01438567