Study to Evaluate The Analgesic Efficacy and Safety of Intravenous Paracetamol in Subjects With Postoperative Pain After Total Hip Arthroplasty
A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty
1 other identifier
interventional
86
1 country
5
Brief Summary
The main purpose is to evaluate the analgesic efficacy of 1g of intravenous (Iv) paracetamol versus i.v. placebo, administered every 6h, as measured by the reduction of the 24-hour cumulative dose of the opioid tramadol in the treatment of postoperative pain following total hip arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 pain
Started Apr 2006
Typical duration for phase_4 pain
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 23, 2006
CompletedFirst Posted
Study publicly available on registry
June 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedNovember 4, 2015
October 1, 2015
1.8 years
June 23, 2006
October 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-hour cumulative dose of tramadol
24 hours, defining TO as the start time of the first dose of study drug
Secondary Outcomes (1)
Sum of tramadol and Boluses number, Time from study drug start to tramadol start, total opioid use, Pain intensity scores/diff. from baseline, Global efficacy evaluation, Number of AE, Sedation level, Nausea/Vomiting, Antiemetic needs.
24 hours, defining TO as the start time of the first dose of study drug
Study Arms (2)
A
ACTIVE COMPARATORB
PLACEBO COMPARATORInterventions
IV Solution, Intravenous, 100 mL (10 mg/mL), 4 times at 6-hour intervals, 24 hours
Eligibility Criteria
You may qualify if:
- Spinal anesth
- BMI 10-35
- No pain conditions/concom med may alter pain quantif.
You may not qualify if:
- Other add. surgery
- Liver/Renal function altered
- coagulation alterations
- Respir / Cardiac insufficiency
- Agents affecting microsomal syst
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Local Institution
Alcorcón, 28922, Spain
Local Institution
Barcelona, 08024, Spain
Local Institution
Madrid, 28007, Spain
Local Institution
Madrid, 28041, Spain
Local Institution
Vizcaya, 48903, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2006
First Posted
June 26, 2006
Study Start
April 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
November 4, 2015
Record last verified: 2015-10