Efficacy of Oxycodone/Naloxone, Compared to Oxycodone, for the Reduction of Intensity of Opioid-induced Constipation in Pain Patients
Information source: Mundipharma SAS
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation; Pain
Intervention: Oxycodone Naloxone (Drug); Oxycodone PR Tablets (Drug)
Phase: Phase 3
Sponsored by: Mundipharma SAS
Margaret C Wilson, Email: firstname.lastname@example.org
The primary objective of this trial is to study the efficacy of oxycodone/naloxone prolonged
release tablets (OXN PR), compared to oxycodone prolonged release tablets (Oxy PR), for the
reduction of the intensity of opioid-induced constipation symptoms in patients treated for
cancer or non-cancer pain.
Official title: Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change of intensity of constipation symptoms, as assessed by the BFI from baseline to Day 28. The BFI is the mean value of 3 single items: Ease of defecation; Feeling of incomplete bowel evacuation; Personal judgement of constipation.
Secondary outcome: Change of BFI from baseline (bl) to Days 7,14,21. Change of PAC-SYM score from bl to Days 7,14,21,28. Change of KESS score from bl to Days 7,14,21,28. Frequency of laxative medication use between Day 0 & Day 28. Change of pain as assessed by BPI-SF
Eligible patients with documented cancer or non-cancer pain, either currently receiving a
WHO step II opioid and requiring the initiation of a WHO step III opioid or currently
receiving a WHO step III opioid, and having opioid-related constipation defined by either a
KESS score ≥9 or the current use of laxatives (â¥3 times per week), will be randomly assigned
to receive either OXN PR or Oxy PR. Randomisation will be stratified on the cause of pain:
cancer or non-cancer.
Any patient having completed the study and wishing to receive OXN PR afterwards may enter an
optional open extension phase. During this phase, all patients will receive OXN PR and be
managed as per the usual practice in the center until commercial OXN PR is available in
France (with a limit of 1 year after Day 28). Adverse events will be assessed at each visit.
Minimum age: 18 Years.
Maximum age: N/A.
1. Male or female patient aged 18 years or older.
2. With cancer pain or non-cancer pain such as chronic low back pain, osteoarthritis or
3. Either currently receiving a WHO step II opioid and requiring the initiation of a WHO
step III opioid (due to a lack of efficacy of the step II opioid) expected to last 28
days or more, or currently receiving a WHO step III opioid expected to last further
28 days or more.
4. Having opioid-related constipation defined by either a KESS score â¥ 9 or the current
use of laxatives (at least 3 times per week).
5. Able, in the opinion of the Investigator, to comply with the study protocol.
6. Women of childbearing potential must have a negative urine pregnancy test result at
inclusion (test under supervision of the investigator) and use an effective birth
control method. Women of non-childbearing potential must be postmenopausal or
surgically sterile (hysterectomy and/or bilateral oophorectomy).
7. Having received oral and written information about the study protocol and signed a
written, informed consent to participate.
1. Pregnancy or breastfeeding.
2. Known contraindication or hypersensitivity to oxycodone, naloxone, bisacodyl, any
chemically close substance, and ingredients.
3. Clinically significant impairment of cardiovascular, respiratory, liver or kidney
function disease, as determined by medical history, clinical laboratory tests, ECG
results, and physical examination, that in the opinion of the Investigator may
present a risk upon exposure to the study medication.
4. Known or suspected unstable brain or spinal cord metastases that may require changes
in steroid treatment throughout the duration of the study.
5. Increased intracranial pressure.
6. Evidence of clinically significant gastrointestinal disease (e. g., paralytic ileus,
peritoneal carcinosis), significant structural abnormalities of the gastrointestinal
tract (e. g., scarring, obstruction etc) either related or not related to the
underlying cancer or disease progression.
7. Rheumatoid arthritis, as co-medication may have an impact on the study results,
especially if co-medication is not stable within the study.
8. Surgery completed prior to the start of the study, or planned surgery during the
study that would influence pain or bowel function during the study or preclude
completion of the study.
9. Cyclic chemotherapy in the two weeks before inclusion or planned during the study
that has shown in the past to influence bowel function. Patients having their first
cycle of chemotherapy during the 2 weeks before the inclusion visit or during the
study they should not be included in the study.
10. Radiotherapy that, in the investigators opinion, would influence bowel function or
pain during the study.
11. Treatment with an opioid receptor antagonist in the month preceding inclusion.
12. History of alcohol, opioid or other drug abuse.
13. Current treatment with another psychoactive drug that, in the opinion of the
Investigator, may present a risk when associated with an opioid.
14. Any somatic or psychic condition that, in the opinion of the Investigator, may
compromise the ability of the patient to understand and comply with the study
protocol or to provide informed consent to participate.
15. Patient who participated in a clinical research involving a new chemical entity or an
experimental drug within 30 days of study entry. Concurrent enrolment in another
clinical trial is not permitted unless the sole purpose of the other trial at the
time of the OXN3505 inclusion visit is for long-term follow-up/survival data.
Locations and Contacts
Margaret C Wilson, Email: email@example.com
HÃ´pital Louis Pradel, 69500 Bron, France; Recruiting
Starting date: February 2010
Last updated: March 22, 2010