PainPhase 4NCT02389361

Comparison of Oral Zaldiar With Intravenous Paracetamol and Tramadol

A Phase 4 study testing Zaldiar and Paracetamol-Tramadol in people with Pain, run by Astes.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: Zaldiar and Paracetamol-Tramadol
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: No sites listed yet
Study dates: Apr 2011to Oct 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients incoming for inguinal hernia repair

Who cannot join

Preoperative abuse of analgesics

About this study

Official title: ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair

Read the detailed description

Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.

Conditions: Pain
Being tested: Zaldiar, Paracetamol-Tramadol
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZaldiarDrug
Also called Oral Zaldiar
Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
Paracetamol-TramadolDrug
Also called Intravenous Paracetamol and Tramadol
Postoperative analgesia with intravenous Paracetamol and Tramadol

Study groups in NCT02389361
Study group	Role	What they receive
Group Z	Experimental	Postoperative Analgesia with Zaldiar Receives: Drug: Zaldiar
Group PT	Active comparator	Postoperative Analgesia with Paracetamol-Tramadol Receives: Drug: Paracetamol-Tramadol

What is being measured

The primary outcome is the main question the study is designed to answer.

Acute Pain
Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale.
Measured: In recovery room

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Oct 2011

First posted17 Mar 2015 (estimated)
Study startApr 2011
Primary completionSep 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02389361
Sponsor's protocol ID: ASTES - ZIH
Status last verified: Jul 2018
First submitted: 27 Feb 2015
Last updated: 21 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair
ClinicalTrials.gov ID: NCT02389361
Acronym / sponsor ID: ASTES - ZIH
Conditions: Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: AstesUniversity, hospital or other
Study start: Apr 2011
Primary completion: Sep 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 17 Mar 2015 (estimated)
Results: Posted 13 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group Z	Experimental	Drug: ZaldiarPostoperative Analgesia with Zaldiar
Group PT	Active comparator	Drug: Paracetamol-TramadolPostoperative Analgesia with Paracetamol-Tramadol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients incoming for inguinal hernia repair

Key exclusion criteria (1 listed)

Preoperative abuse of analgesics

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
ZaldiarAlso: Oral ZaldiarPostoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)	Drug	Group Z
Paracetamol-TramadolAlso: Intravenous Paracetamol and TramadolPostoperative analgesia with intravenous Paracetamol and Tramadol	Drug	Group PT

Primary outcome

Acute Pain
Time frame: In recovery room
Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale.

Results and safety

Results posted to the registry on 13 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group Z	24	24
Group PT	27	27

Primary outcome: Acute Pain

Time frame: In recovery room. Median (Standard Deviation). Unit: units on a scale

Measure	Group Z n = 24	Group PT n = 27
Value	1.5 (1.28)	1.74 (1.86)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group Z	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Group PT	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Eric Deflandre study director

Astes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Zaldiar and Paracetamol-Tramadol in people with Pain, run by Astes.

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 1 inclusion and 1 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Acute Pain (time frame: In recovery room). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02389361.

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 21 Aug 2018.