A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant pain

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-003752-19-HU
• Date of registration: 02/12/2004
• Prospective Registration: Yes
• Primary sponsor: Mundipharma Research GmbH & Co.KG
• Public title: A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant pain
• Scientific title: A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant pain
• Date of first enrolment: 01/02/2005
• Target sample size: 750
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003752-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Czech Republic, Denmark, Hungary, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1.Males and females at least 18 years of age. (Females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded within 72 hours prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study.)
2.Documented history of moderate to severe chronic pain of low back that requires around-the-clock opioid therapy.
3.Nonmalignant low back pain (for example osteoarthrosis / osteoarthritis of spine, deforming spondylosis, spondylolisthesis, disc herniation / sciatica, spinal stenosis)adequately managed by an opioid analgesic for at least the past 2 weeks.
4.Subjects who require continuation of daily opioid analgesic treatment and are likely to benefit from chronic opioid therapy (WHO step III opioid) for the duration of the study.
5.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 as evidenced by providing written, informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.Any history of hypersensitivity to oxycodone, naloxone, or related products.
2.Subjects currently taking the equivalent of <10 mg or >40 mg/d oxycodone. (Refer to Appendix 12.2: Drug Conversion Tables.)
3.Subjects diagnosed with cancer, not including basal cell carcinoma.
4.Active alcohol or drug abuse.
5.Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.
6.Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>3 times the upper limit of normal) or an abnormal total bilirubin and/or creatinine level(s) (outside of the reference range).
7.Surgery completed <= 2 months prior to the start of the Screening Period, planned surgery during the12-week Double-blind Phase, or any other pharmacological or non-pharmacological intervention that would influence pain during the study (not including chemotherapy) or preclude completion of the study.
8.Subjects presently taking, or who have taken, naloxone or an experimental drug <=30 days prior to the start of the Screening Period.
9.Subjects with a history of 2 or greater low back surgeries.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Moderate to severe chronic pain of low back that requires around-the-clock opioid therapy.
MedDRA version: 7.0 Level: pt Classification code 10003988

Intervention(s)

Product Name: Oxycodone/Naloxone prolonged release tablets 10/5 mg
Product Code: OXN 10/5
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hydrochloride
CAS Number: 124-90-3
Other descriptive name: 4,5-alpha-Epoxy-14-hydroxy-3-methoxy -17-methylmorphinan-6-one hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Naloxone hydrochloride
CAS Number: 51481-60-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Oxycodone/Naloxone prolonged release tablets 20/10 mg
Product Code: OXN 20/10
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hydrochloride
CAS Number: 124-90-3
Other descriptive name: 4,5-alpha-Epoxy-14-hydroxy-3-methoxy -17-methylmorphinan-6-one hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
INN or Proposed INN: Naloxone hydrochloride
CAS Number: 51481-60-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: Oxycodone/Naloxone prolonged release tablets 40/20 mg
Product Code: OXN 40/20
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hydrochloride
CAS Number: 124-90-3
Other descriptive name: 4,5-alpha-Epoxy-14-hydroxy-3-methoxy -17-methylmorphinan-6-one hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: Naloxone hydrochloride
CAS Number: 51481-60-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: OxyContin Tablets 10 mg
Product Name: OxyContin 10 mg, prolonged release tablet
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone hy

Primary Outcome(s)

Secondary Objective: •To determine sleep quality during treatment with OXN compared with placebo and OXY compared with placebo as measured by the sleep interference item of the Brief Pain Inventory Short Form (BPI-SF)5.
•To determine the total amount of rescue medication used per day (24 hours) by subjects receiving OXN, OXY, and placebo.
•To determine subjects’ global (12-week/early discontinuation) satisfaction with the study medication during the Double-blind Phase using the Patient Global Impression of Change scale (PGIC).

Primary end point(s): Pain Event.
A pain event is demonstrated by unacceptable pain control for 2 consecutive days. Each pain event is 2 discrete days, eg, there can be a maximum of 2 pain events in 4 days. A day of unacceptable pain control is defined as:
1) Pain Intensity Scale (“Average Pain over 24 Hours”) score = 5 or
2) Pain Intensity Scale (“Pain Right Now”) score = 5 accompanied by rescue medication of OXY IR at 1/4 the total daily oxycodone daily dose of OXY/OXN dosing = 2 times over one day.
OR subjects may have a pain event by:
3) Study discontinuation due to lack of therapeutic effect.

Main Objective: To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.

Secondary ID(s)

OXN3401