Pain, PostoperativePhase 3NCT00508495
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain
A Phase 3 study testing Paracetamol (acetaminophen), Paracetamol 1% solution and 0.9% sodium chloride solution in people with Pain, Postoperative, run by Baxter Healthcare Corporation at 8 sites in Hungary.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Paracetamol (acetaminophen), Paracetamol 1% solution and 0.9% sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 8 sitesHungary
- Study dates
- Aug 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Hungary8 sites
Réthy Pál Kórház-Rendelőintézet
Békéscsaba
Semmelweis Egyetem Ortopédiai Klinika
Budapest
Esztergom Város Önkormányzat Vaszary Kolos Kórháza
Esztergom
Petz Aladár Megyei Oktató Kórház
Győr
Bács-Kiskun Megyei Önkormányzat Kórháza
Kecskemét
SZTE ÁOK Ortopédiai Klinika
Szeged
Fejér Megyei Szent György Kórház
Székesfehérvár
Tolna Megyei Önkormányzat Balassa János Kórháza
Szekszárd
About this study
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
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).
- Conditions
- Pain, Postoperative
- Being tested
- Paracetamol (acetaminophen), Paracetamol 1% solution, 0.9% sodium chloride solution
- Keywords
- pain, postoperative, replacement, total hip, total hip replacement, arthroplasty, replacement, hip
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol (acetaminophen)Drug
Also called Perfalgan
Four 100 mL, 15 min IV infusions at six hour intervals
Paracetamol 1% solutionDrug
Four 100 mL, 15 min IV infusions at six hour intervals
0.9% sodium chloride solutionDrug
Also called Normal saline solution
Four 100 mL, 15 min IV infusions at six hour intervals
| Study group | Role | What they receive |
|---|---|---|
| Test drug | Experimental | Not described Receives: Drug: Paracetamol 1% solution |
| Reference drug | Active comparator | Not described Receives: Drug: Paracetamol (acetaminophen) |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of PCA-administered morphine consumed during first six hours of study drug treatment
Measured: 6 hours from first (of four) study drug doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services
- Investigators
- Keyvan Tadjalli Mehr, MD, MSc, Study director, Baxter Deutschland GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508495
- Sponsor's protocol ID
- R-01270-A016
- Other IDs
- EudraCT 2006-004075-36
- Status last verified
- Aug 2011
- First submitted
- 26 Jul 2007
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00508495
- Acronym / sponsor ID
- R-01270-A016
- Conditions
- Pain, Postoperative
- Keywords
- pain, postoperative, replacement, total hip, total hip replacement, arthroplasty, replacement, hip
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test drug | Experimental | Drug: Paracetamol 1% solution |
| Reference drug | Active comparator | Drug: Paracetamol (acetaminophen) |
| Placebo | Placebo comparator | Drug: 0.9% sodium chloride solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol (acetaminophen)Also: PerfalganFour 100 mL, 15 min IV infusions at six hour intervals | Drug | Reference drug |
| Paracetamol 1% solutionFour 100 mL, 15 min IV infusions at six hour intervals | Drug | Test drug |
| 0.9% sodium chloride solutionAlso: Normal saline solutionFour 100 mL, 15 min IV infusions at six hour intervals | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keyvan Tadjalli Mehr, MD, MSc study director
Baxter Deutschland GmbH
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol (acetaminophen), Paracetamol 1% solution and 0.9% sodium chloride solution in people with Pain, Postoperative, run by Baxter Healthcare Corporation at 8 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.