Phase 3
N=234
OxyNorm Capsules in Post-Operative Pain Study
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01675635 ↗Enrolled (actual)
234
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose) — 46.21; 45.48; 20.21; 19.94 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OxyNorm Capsules (Drug); Morphine tablet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose) |
46.21; 45.48; 20.21; 19.94 | — |
| SECONDARY VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose |
46.21; 45.48; 46.21; 45.48; 29.87; 29.80 | — |
| SECONDARY The Use of Rescue Analgesics During the 24-hour Observation Period |
7; 5; 8; 2; 1; 0 | — |
| SECONDARY VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose) |
55.16; 53.91; 28.81; 28.15 | — |
| SECONDARY Sleeping Quality Assessment |
31; 36; 38; 48; 38; 26 | — |
| SECONDARY Satisfaction With Pain Control |
38; 43; 54; 58; 19; 12 | — |
| SECONDARY Comparison of the Total Amount of Study Drugs Used During the 24 Hours |
18.50; 39.82 | — |
Summary
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.
Eligibility Criteria
Inclusion Criteria
- Patients of either sex aged 18 to 80 years inclusive.
- Patients who have given written informed consent to participate in the study.
- Able and willing to communicate with the investigator and his/her staff.
- Free of anesthesia as assessed through question and answer interaction with nurse at which time oral medication is indicated.
- Reporting "moderate" or "severe" pain (VAS ≥ 4) related to surgery and requesting analgesics for pain relief.
Exclusion Criteria
- Patients have developed tolerance to or dependence on narcotic analgesics and/or alcohol.
- Patients with ASA ≥ 3 .
- Have any concomitant medical condition that would be adversely affected by analgesics or confound the quantification of analgesia, or could affect the absorption, metabolism or excretion of the study drugs in any clinically significant fashion.
- Have known hypersensitivity to any of the study medications or related agents.
- Have taken analgesic medications within three hours (wash-out) prior to dosing.
- Have developed complications from the surgical procedure that would confound the study.
- Have a history of severe iatrogenic adverse experiences.
- Mothers nursing their infant during the 24 hours following study drug administration, or pregnant women.
- Patient with Nothing Per Os (NPO) as stated in patient's chart or physician's order.
- Surgery in patients with epidural anesthesia
- Patients with Severe impairment of liver at preoperative stage (ALT, AST ≥ 1.5 times upper limit) and abnormal renal function.
- Patients with medical history of recovering from abnormal surgery anesthesia.
- Patients with medical history of hypertension (Systolic blood pressure ≥ 180Hg, Diastolic blood pressure 110Hg).
- Patients with shock.
- Patients with COPD.
- According to investigator to determine, patients are in addition the inclusion criteria and exclusion criteria for any other reason than not suitable in this study.
Data sourced from ClinicalTrials.gov (NCT01675635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.