MedPath

Targin for Non-cancer Pain

Phase 3
Completed
Conditions
Non Cancer Pain
Interventions
Drug: Oxycodone/naloxone prolonged release tablets
Registration Number
NCT01918098
Lead Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Brief Summary

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release tablets (OXY) based on the Bowel Function Index (BFI)

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
230
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Oxycodone prolonged release tabletsOxycodone/naloxone prolonged release tabletsDose strength:5mg,10mg, 20mg,PO,q12h.daily dose from 10mg to 50mg.treatment duration:12 weeks
Oxycodone/naloxone prolonged release tabletsOxycodone/naloxone prolonged release tabletsDose strength:5/2.5 mg,10/5mg, 20/10mg,PO,q12h.daily dose from 10/5mg to 50/25mg.treatment duration:12 weeks
Primary Outcome Measures
NameTimeMethod
Bowel function index(BFI) 12 Weeks12 weeks
Secondary Outcome Measures
NameTimeMethod
Modified BPI-SF-Average Pain over the last 24 hours12 weeks

Trial Locations

Locations (31)

Guangzhou First People's Hospital

🇨🇳

Guangzhou, Guangdong, China

Second Affiliated Hospital of Shan Tou University Medical College

🇨🇳

Shan Tou, Guangdong, China

Hebei General Hospital

🇨🇳

Shijiazhuang, Hebei, China

Beijing friendship hospital

🇨🇳

Beijing, China

Beijing Tiantan Hospital

🇨🇳

Beijing, China

Beijing Union hospital

🇨🇳

Beijing, China

Peking Union Medical College Hospital

🇨🇳

Beijing, China

Peking University Third Hospital

🇨🇳

Beijing, China

The first affiliated hospital of Bengbu medical collage

🇨🇳

Bengbu, China

The third Xiangya hospital of central south university

🇨🇳

Changsha, China

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Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
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