Clinical trial · Interventional
To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain
Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pain | — | UNRESOLVED | — |
| Non-malignant Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Naloxone | Drug | — | UNRESOLVED |
| Oxycodone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OXN PR HST
- description
- Prolonged release oxycodone/naloxone higher strength tablets
- interventionNames
- Drug: Oxycodone
- type
- ACTIVE_COMPARATOR
- label
- OXN PR LST
- description
- Prolonged release oxycodone/naloxone lower strength tablets
- interventionNames
- Drug: Naloxone
Primary outcomes (2)
- measure
- (mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
- timeFrame
- 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain. * Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy Exclusion Criteria * Females who are pregnant or lactating. * Subjects with evidence or significant structural abnormalities of the gastrointestinal tract. * Subjects with evidence of impaired liver/kidney function upon entry into the study.
References
Publications (0)
Data not yet available