Recruitment

Recruitment Status
Completed
Estimated Enrollment
270

Inclusion Criterias

Subjects are either taking opioid medication or willing to take opioids to treat their pain
Males or females, 18 years of age or older
Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
...
Subjects are either taking opioid medication or willing to take opioids to treat their pain
Males or females, 18 years of age or older
Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
Patients who are willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectable, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomized partner
Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale."
Clinical diagnosis of musculo-skeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1. Possible etiologies are conditions related to intervertebral disc disease, spondylolisthesis and osteoarthritis; other similar non-malignant diseases are also eligible.
Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements are evidenced by providing written informed consent
Patients with non-malignant pain that require around-the-clock opioid therapy (oxycodone equivalent of ≥10 mg/day and ≤50 mg/day) who are likely to benefit from WHO step III opioid therapy for the duration of the study

Exclusion Criterias

Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine)
Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period)
...
Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine)
Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period)
Subjects with evidence of significant structural abnormalities of the gastrointestinal tract or any diseases/conditions that affect bowel transit
Subjects diagnosed with cancer, not including basal cell carcinoma
Females who are pregnant (positive β-hCG test) or lactating
Subjects with evidence of impaired liver/kidney function upon entry into the study defined as aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels >3 times the upper limit of normal; gamma glutamyltranspeptidase (GGT or GGTP) ≥ 5 times the upper limit of normal; total bilirubin level outside of the reference range; and/or creatinine level outside of the reference range or >2 mg/dl, or in the investigator's opinion, liver and/or kidney impairment to the extent that the subject should not participate in this study
Subjects presently taking, or who had taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).
Any history of hypersensitivity or with any contraindication to oxycodone, naloxone, bisacodyl, or related products
Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week Double-blind Phase that may have affected GI motility or pain
Subjects with Rheumatoid Arthritis (RA)
Subjects with active alcohol or drug abuse and/or history of opioid abuse
Subjects who have required treatment for the diagnosis of irritable bowel syndrome (IBS)
Subjects currently taking the equivalent of > 50 mg/day Oxycodone PR
Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination, that will place the subject at risk upon exposure to the study medication or that could confound the analysis and/or interpretation of the study results

Summary

Conditions
Non Cancer Pain
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Subjects are either taking opioid medication or willing to take opioids to treat their pain
Males or females, 18 years of age or older
Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
...
Subjects are either taking opioid medication or willing to take opioids to treat their pain
Males or females, 18 years of age or older
Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.
Patients who are willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectable, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomized partner
Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale."
Clinical diagnosis of musculo-skeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1. Possible etiologies are conditions related to intervertebral disc disease, spondylolisthesis and osteoarthritis; other similar non-malignant diseases are also eligible.
Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements are evidenced by providing written informed consent
Patients with non-malignant pain that require around-the-clock opioid therapy (oxycodone equivalent of ≥10 mg/day and ≤50 mg/day) who are likely to benefit from WHO step III opioid therapy for the duration of the study

Exclusion Criterias

Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine)
Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period)
...
Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine)
Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period)
Subjects with evidence of significant structural abnormalities of the gastrointestinal tract or any diseases/conditions that affect bowel transit
Subjects diagnosed with cancer, not including basal cell carcinoma
Females who are pregnant (positive β-hCG test) or lactating
Subjects with evidence of impaired liver/kidney function upon entry into the study defined as aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels >3 times the upper limit of normal; gamma glutamyltranspeptidase (GGT or GGTP) ≥ 5 times the upper limit of normal; total bilirubin level outside of the reference range; and/or creatinine level outside of the reference range or >2 mg/dl, or in the investigator's opinion, liver and/or kidney impairment to the extent that the subject should not participate in this study
Subjects presently taking, or who had taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).
Any history of hypersensitivity or with any contraindication to oxycodone, naloxone, bisacodyl, or related products
Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week Double-blind Phase that may have affected GI motility or pain
Subjects with Rheumatoid Arthritis (RA)
Subjects with active alcohol or drug abuse and/or history of opioid abuse
Subjects who have required treatment for the diagnosis of irritable bowel syndrome (IBS)
Subjects currently taking the equivalent of > 50 mg/day Oxycodone PR
Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination, that will place the subject at risk upon exposure to the study medication or that could confound the analysis and/or interpretation of the study results

Locations

Fuzhou
Changsha
Beijing
Shanghai
Shenyang
...
Fuzhou
Changsha
Beijing
Shanghai
Shenyang
Changsha
Wuhan
Guangzhou, Guangdong
Guangzhou
Xuzhou
Zhejiang
Shanghai
Changsha
Wuhan
Jinan
Guizhou
Shanghai
Harbin
Bengbu
Beijing
Beijing
Chongqing
Shijiazhuang, Hebei
Chongqing
Beijing
Beijing
Shan Tou, Guangdong
Chengdu
Wuhan
Shanghai
Shantou

Tracking Information

NCT #
NCT01918098
Collaborators
Not Provided
Investigators
Study Director: Victoria Yu Mundipharma, China