NCT01476774

NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.

Conditions

• Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)

Interventions

Type	Name	Description
DRUG	Buprenorphine Transdermal System	Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given. maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .
DRUG	Buprenorphine Transdermal System	Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given. maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control .

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-06-01
• First posted: 2011-11-22
• Last updated: 2015-07-08

Locations

1 site across 1 country: China