Trials / Completed
CompletedNCT01313780
A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients
A 4-week Multicentre, Randomized, Open Label, Parallel Group, Active Control Phase IV Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone in Comparison With Oxycontin in Korean Patients With Cancer Pain(TOP)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Mundipharma Korea Ltd · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Objectives: To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity 1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks 2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events
Detailed description
This will be a 4-week multicentre, randomized, open label, parallel group, active control study to evaluate efficacy and safety of Targin in comparison with Oxycontin in Korean patients with cancer pain who are administered weak opioid or naïve patients including patient not on the long term strong opioid medication within 3 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxycodone/Naloxone | Dose and administration : Upto 40mg B.I.D per daily. |
| DRUG | Oxycodone(single compound) | Dose and administration : Upto 40mg B.I.D per daily. |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2013-10-01
- Completion
- 2014-06-01
- First posted
- 2011-03-14
- Last updated
- 2017-12-22
- Results posted
- 2016-10-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01313780. Inclusion in this directory is not an endorsement.