Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain
- Registration Number
- NCT01885182
- Lead Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Brief Summary
To Determine the Safety and Efficacy of Oxycodone / Naloxone Prolonged Release Tablets compared to Oxycodone PR in Subjects with Moderate to Severe, Chronic Cancer Pain
- Detailed Description
This is a randomised, double-blind, double-dummy, parallel group study using OXN and OXY PR to treat moderate to severe, chronic cancer pain. Subjects with documented history of cancer pain that requires around the clock opioid therapy will be included. Subjects must have a medical history of constipation that was induced by, or worsened by their opioid therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone/Naloxone Oxycodone/Naloxone 5/2.5mg, 10/5mg, 20/10mg or 40/20mg Oxycodone Oxycodone 5mg, 10mg, 20mg or 40mg
- Primary Outcome Measures
Name Time Method The Change of BFI-Bowel Function Index at visit8 Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study BFI is the mean of NAS for the following items:
* Ease of defecation
* Feeling of incomplete bowel evacuation.
* Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome.The Change of BPI-SF at visit8 Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome.
- Secondary Outcome Measures
Name Time Method The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study) At Visit 5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)\*) for OXN PR and OXY PR groups.
The Change of Rescue Medication Use From visit5 to visit8 visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study) The average daily dose of rescue medication (Morphine Sulfate Tablet) for OXN PR group and OXY PR group at Visit 5(first week of double blind) and at Visit 8(last week of double blind).
The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9 Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5) to compare the Modified SOWS's Change from Visit 1(day-10-0) to Visit 3(day1),Change from Visit 1 to Visit 9(day35).The SOWS was scored as the total of the 15 symptoms. each symptoms score is 0(not at all)-4(extremely).total score range is 0-60.Do higher values represent a better outcome.
To Assess Quality of Life Based on EQ-5D Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study) To assess quality of life based on EQ-5D by subjects evaluation via patient dairy.the quality of life based on EQ-5D at Visit1 (day-10-0) and end of treatment Visit8(day28). The scarc range is 0(the best state you can imagine)-100(the worst state you can imagine).Do higher values represent a worse outcome.
The Change of Bowel Movement by Visit visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study) Number pf bowel movements(BM) and number of days the subjects had a bowel movement in the last 7 days before the study visit will be summarized at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28)..
The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study) To compare the change of Brief pain inventory short-form (BPI-SF) 11 indivial items (except for pain in average) at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28). each item range (except for how much relief from treatment /medication last 24hours is 0-100%,do higher values represent a better outcome.) is 0-10, do higher values represent a worse outcome.
The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8 visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable At Visit5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)\*) for OXN PR and OXY PR groups
Trial Locations
- Locations (28)
The sixth hospital of shanghai
🇨🇳Shanghai, China
Tianjin Cancer Hospital
🇨🇳Tianjin, China
Beijing Friendship Hospital
🇨🇳Beijing, China
Fuzhou General Hospital of Nanjing Military Command of PLA
🇨🇳Fuzhou, Fujian, China
The central Hospital of Jinan
🇨🇳Jinan, Shandong, China
307th hospital of Chinese People's medical sciences
🇨🇳Beijing, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Sun yat-sen univercity cancer center
🇨🇳Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Beijing Hospital
🇨🇳Beijing, China
Jiangsu Cancer hospital
🇨🇳Nanjing, Jiangsu, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Hebei Medical University Fouth Hospital
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Harbin Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Hubei Cancer Hospital
🇨🇳Changsha, Hubei, China
The second hospital of Nanjing Medical university
🇨🇳Nanjing, Jiangsu, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
The second affiliated hospital of Dalian Medical university
🇨🇳Dalian, Liaoning, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
Tangdu Hospital,Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
The first people's hospital of shanghai
🇨🇳Shanghai, China
Pejing Union Medical College Hospital
🇨🇳Beijing, China
General Hospital of Beijing Military
🇨🇳Beijing, China