OxyNorm Capsules in Post-Operative Pain Study

NCT01675635 | Completed Phase 3 Results DMC

• 1 other identifier: OXYC11-CN-304
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)

  To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison Visual Analogue Scale 0 10 20 30 40 50 60 70 80 90 100 0 means no pain; 100 means pain as bad as you can image at resting stage

  Baseline and 6h (±20min)

Secondary Outcomes (6)

• VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose

  Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)

• The Use of Rescue Analgesics During the 24-hour Observation Period

  24 hours after the first dose.

• VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)

  Baseline and 6h (±20min)

• Sleeping Quality Assessment

  24 hours after administration of first dose

• Satisfaction With Pain Control

  24 hours after administration of first dose

Study Arms (2)

OxyNorm Capsules

EXPERIMENTAL

To determine the efficacy and safety of OxyNorm Capsules.

Drug: OxyNorm Capsules

Morphine tablet

ACTIVE COMPARATOR

To determine the efficacy and safety of Morphine tablet.

Other: Morphine tablet

Interventions

OxyNorm Capsules DRUG

dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours

Also known as: OxyNorm

OxyNorm Capsules

Morphine tablet OTHER

dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.

Also known as: Morphine

Morphine tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma (China) Pharmaceutical Co. Ltd: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Ms. Dan Zhu, Clinical operation and quality lead of the study
• Organization: Mundipharma (China) pharmaceutical Co, LTD.

medical.mcpc@mundipharma.com.cn

0086-10-65636800

Study Officials

• XinMin Wu, Prof.

  Peking University 1st Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: August 30, 2012
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 26, 2018
• Results First Posted: February 26, 2018

Record last verified: 2017-11