Norspan Versus Oxycontin as Postoperative Painkiller to P... | NCT00964808

Studies
Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur

NCT00964808

Sponsor

Vejle Hospital

Status

Completed

Last Update Posted

Dec 8, 2014Estimated

Enrollment

76Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Buprenorphine
Oxycodone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

May 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2014

Last Update Posted Date

Dec 8, 2014Estimated

Name	Class
Norpharma A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine.

This is a randomized pilot study where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip fractures. The investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No clinical study about the effect of Norspan as acute painkiller has never been done before. Can the investigators get the patients mobilized earlier with less adverse effects?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buprenorphine	Experimental	Double dummy; Group A: Active Buprenorphine and placebo oxycodone	Drug: Buprenorphine
Oxycodone	Experimental	Double Dummy: Group B: Placebo Buprenorphine and Active Oxycodone	Drug: Oxycodone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine	Drug	Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.	Buprenorphine

Measure	Description	Time Frame
Mobilization measured daily using Cumulated Ambulation Score.		12 days

Measure	Description	Time Frame
Pain intensity measured daily on a verbal rating scale		12 days
Adverse effects		12 days + 14 days
Opioid consumption.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females age 18 years or more
X-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with DHS or PFN.
Subjects must have 7 or more points in the Hindsøes test.

Exclusion Criteria:

Subjects where spinal anaesthesia cannot be applied.
Subject in Plavix® treatment seven days before admission to the hospital.
Subjects with extracapsular hip fracture due to bone metastasis.
Subjects with a BMI over 30.
Subjects under 45 kg.
Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior admission to the hospital.
Substance or alcohol abuse, or subjects who, in the opinion of the investigator have demonstrated addictive or substance abuse behavior.
Untreated depression or other psychiatric disorder in such a way that participation in the study may in the opinion of the investigator pos an unacceptable risk to the subject.
Dermatological disorder at any relevant patch application site.
Any contraindications listed in the Summary of Product Characteristics for Norspan®, OxyNorm® and OxyContin®.
Patient does not tolerate oxynorm.
User of wheelchair.
Daily use of morphine before hospitalization.
More than one fracture. Patients with myasthenia gravis. Patients with severe respiratory function. Patients know need re-operation women of childbearing potential must have a negative pregnancy test and be non-lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010149	Pain, Postoperative
D006620	Hip Fractures

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds