Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
This study has been completed.
Sponsor:
Baxter Healthcare Corporation
Collaborator:
MDS Pharma Services
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00508495
First received: July 26, 2007
Last updated: August 10, 2011
Last verified: August 2011
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Purpose
The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).
| Condition | Intervention | Phase |
|---|---|---|
|
Pain, Postoperative |
Drug: Paracetamol (acetaminophen) Drug: Paracetamol 1% solution Drug: 0.9% sodium chloride solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model |
Resource links provided by NLM:
MedlinePlus related topics:
Hip Replacement
Drug Information available for:
Acetaminophen
U.S. FDA Resources
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- Amount of PCA-administered morphine consumed during first six hours of study drug treatment [ Time Frame: 6 hours from first (of four) study drug doses ] [ Designated as safety issue: No ]
| Enrollment: | 148 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Test drug |
Drug: Paracetamol 1% solution
Four 100 mL, 15 min IV infusions at six hour intervals
|
| Active Comparator: Reference drug |
Drug: Paracetamol (acetaminophen)
Four 100 mL, 15 min IV infusions at six hour intervals
Other Name: Perfalgan
|
| Placebo Comparator: Placebo |
Drug: 0.9% sodium chloride solution
Four 100 mL, 15 min IV infusions at six hour intervals
Other Name: Normal saline solution
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
- Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.
Exclusion Criteria:
- Another acute or chronic painful physical condition
- Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
- Inability to use and understand Visual Analog Scale and Verbal Rating Score
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508495
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508495
Locations
| Hungary | |
| Semmelweis Egyetem Ortopédiai Klinika | |
| Budapest, Hungary | |
| Réthy Pál Kórház-Rendelőintézet | |
| Békéscsaba, Hungary | |
| Esztergom Város Önkormányzat Vaszary Kolos Kórháza | |
| Esztergom, Hungary | |
| Petz Aladár Megyei Oktató Kórház | |
| Győr, Hungary | |
| Bács-Kiskun Megyei Önkormányzat Kórháza | |
| Kecskemet, Hungary | |
| SZTE ÁOK Ortopédiai Klinika | |
| Szeged, Hungary | |
| Fejér Megyei Szent György Kórház | |
| Szekesfehervar, Hungary | |
| Tolna Megyei Önkormányzat Balassa János Kórháza | |
| Szekszárd, Hungary | |
Sponsors and Collaborators
Baxter Healthcare Corporation
MDS Pharma Services
Investigators
| Study Director: | Keyvan Tadjalli Mehr, MD, MSc | Baxter Deutschland GmbH |
More Information
No publications provided
| Responsible Party: | Keyvan Tadjalli Mehr, MD, MSc/Medical Director, Baxter Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00508495 History of Changes |
| Other Study ID Numbers: | R-01270-A016, EudraCT 2006-004075-36 |
| Study First Received: | July 26, 2007 |
| Last Updated: | August 10, 2011 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Keywords provided by Baxter Healthcare Corporation:
|
pain, postoperative replacement, total hip total hip replacement arthroplasty, replacement, hip |
Additional relevant MeSH terms:
|
Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms Acetaminophen Pharmaceutical Solutions Analgesics |
Analgesics, Non-Narcotic Antipyretics Central Nervous System Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015