Trial · NCT00784810
A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
NCT00784810, Phase 4, Completed, Napp Pharmaceuticals Limited; results first posted 2011-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis. Trials, record NCT00784810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784810
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
- NCT number
- NCT00784810
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 247 participants, actual
- Lead sponsor
- Napp Pharmaceuticals Limited
- Conditions
- Osteoarthritis, Back Pain
- Interventions
- Oxycodone/Naloxone, Codeine/Paracetamol
- First posted
- 2008-11-04
- Last updated
- 2011-11-02
- Results first posted
- 2011-11-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours) | Average daily pain over last 24 hours (at Week 12) | The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours) |
| Secondary | Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups. | Between visit 8 and 9 | To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the "number of intakes of rescue medication" for this period (ie between Visit 8 and Visit 9). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours) | Average daily pain over last 24 hours (at Week 12) | To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data. | Units on a BS-11 scale at Week 12 | MEAN |
| SECONDARY | Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups. | Between visit 8 and 9 | The number of participants for analysis is less due to subject withdrawals or lack of data. | Number of rescue medication intakes | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours) | Oxycodone/Naloxone Tablets (OXN) | 4.2 | Standard Deviation 2.139 | Units on a BS-11 scale at Week 12 | |
| Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours) | Codeine/Paracetamol Tablets | 4.64 | Standard Deviation 2.046 | Units on a BS-11 scale at Week 12 | |
| Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups. | Oxycodone/Naloxone Tablets (OXN) | 13.2 | Standard Deviation 23.31 | Number of rescue medication intakes | |
| Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups. | Codeine/Paracetamol Tablets | 9.4 | Standard Deviation 19.94 | Number of rescue medication intakes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxycodone/Naloxone Tablets (OXN) | 124 | |
| Overall Study | STARTED | Codeine/Paracetamol Tablets | 123 | |
| Overall Study | COMPLETED | Oxycodone/Naloxone Tablets (OXN) | 61 | |
| Overall Study | COMPLETED | Codeine/Paracetamol Tablets | 74 | |
| Overall Study | NOT COMPLETED | Oxycodone/Naloxone Tablets (OXN) | 63 | |
| Overall Study | NOT COMPLETED | Codeine/Paracetamol Tablets | 49 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Oxycodone/Naloxone Tablets (OXN) | 8 | 124 | |
| other | Constipation | Gastrointestinal disorders | Codeine/Paracetamol Tablets | 7 | 123 | |
| other | dyspepsia | Gastrointestinal disorders | Oxycodone/Naloxone Tablets (OXN) | 4 | 124 | |
| other | dyspepsia | Gastrointestinal disorders | Codeine/Paracetamol Tablets | 6 | 123 | |
| other | nausea | Gastrointestinal disorders | Oxycodone/Naloxone Tablets (OXN) | 4 | 124 | |
| other | nausea | Gastrointestinal disorders | Codeine/Paracetamol Tablets | 3 | 123 | |
| other | haemorrhoids | Gastrointestinal disorders | Oxycodone/Naloxone Tablets (OXN) | 0 | 124 | |
| other | haemorrhoids | Gastrointestinal disorders | Codeine/Paracetamol Tablets | 4 | 123 | |
| other | lower respiratory tract infection | Infections and infestations | Oxycodone/Naloxone Tablets (OXN) | 7 | 124 | |
| other | lower respiratory tract infection | Infections and infestations | Codeine/Paracetamol Tablets | 4 | 123 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxycodone/Naloxone Tablets (OXN) | ||
| Total, all-cause mortality | Codeine/Paracetamol Tablets | ||
| Total, other adverse events | Oxycodone/Naloxone Tablets (OXN) | 27 | 124 |
| Total, other adverse events | Codeine/Paracetamol Tablets | 32 | 123 |
| Total, serious adverse events | Oxycodone/Naloxone Tablets (OXN) | 3 | 124 |
| Total, serious adverse events | Codeine/Paracetamol Tablets | 4 | 123 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Oxycodone/Naloxone Tablets (OXN) vs Codeine/Paracetamol Tablets: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00784810
GET https://conductscience.org/api/trials/v1/NCT00784810/events?page=2