Acute and Chronic InflammationPhase 3NCT01670552
Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients
A Phase 3 study testing Nimesulide + Pantoprazole and Naproxen + Esomeprazole in people with Acute and Chronic Inflammation and Dyspepsia, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute and Chronic Inflammation, Dyspepsia
- What is being tested?
- Nimesulide + Pantoprazole and Naproxen + Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteBrazil
- Study dates
- 17 Feb 2016to 17 Mar 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults male or female aged ≥ 18 years old;
- Comply with all the purposes and procedures of the study by signing and dating the Informed Consent.
- Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days.
Who cannot join
- Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
- History of peptic ulcer or gastric surgery;
- Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days;
- Contraindication to the use of NSAIDs or PPIs;
- Renal or hepatic impairment;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
The purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.
Read the detailed description
- Double-blind,randomized, multicenter
- Experiment duration: 14 days
- 03 visits
- Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation
- Adverse events evaluation
- Conditions
- Acute and Chronic Inflammation, Dyspepsia
- Being tested
- Nimesulide + Pantoprazole, Naproxen + Esomeprazole
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimesulide + PantoprazoleDrug
1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.
Naproxen + EsomeprazoleDrug
Also called VIMOVO
1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.
| Study group | Role | What they receive |
|---|---|---|
| Nimesulide + Pantoprazole | Experimental | Nimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days Receives: Drug: Nimesulide + Pantoprazole |
| Naproxen + Esomeprazole | Active comparator | Naproxen + Esomeprazole - 1 tablet each 12 hours for 14 days Receives: Drug: Naproxen + Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 14 days
Secondary outcomes (1)
Incidence of adverse events and dyspeptic complaints during the study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study start17 Feb 2016
- Primary completion28 Oct 2016
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute and Chronic InflammationStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro A. Petersen, MD, Principal investigator, Allergisa Pesquisa Dermato-Cosmetica LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670552
- Sponsor's protocol ID
- NIPEMS1111
- Status last verified
- Apr 2019
- First submitted
- 17 Aug 2012
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.
PubMed 30233140
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients.
- ClinicalTrials.gov ID
- NCT01670552
- Acronym / sponsor ID
- NIPEMS1111
- Conditions
- Acute and Chronic Inflammation, Dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 22 Aug 2012 (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 purpose of this study is to evaluate the safety of an association with one anti-inflammatory and one gastroprotective agent compared to the one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation.
Detailed description
- Double-blind,randomized, multicenter
- Experiment duration: 14 days
- 03 visits
- Evaluate the safety of an association with one anti-inflammatory and one gastroprotective compared to association with one anti-inflammatory and one gastroprotective agent in patients with acute or chronic osteoarticular inflammation
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimesulide + Pantoprazole | Experimental | Drug: Nimesulide + PantoprazoleNimesulide + Pantoprazole- 1 tablet each 12 hours for 14 days |
| Naproxen + Esomeprazole | Active comparator | Drug: Naproxen + EsomeprazoleNaproxen + Esomeprazole - 1 tablet each 12 hours for 14 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults male or female aged ≥ 18 years old;
- Comply with all the purposes and procedures of the study by signing and dating the Informed Consent.
- Acute or chronic osteo-articular injury in need of of anti-inflammatory for a period of 14 days.
Key exclusion criteria (5 listed)
- Pregnant women, or women in childbearing age who are not in use effective contraception or intending to become pregnant during the study period
- History of peptic ulcer or gastric surgery;
- Use of Non-steroidal anti-inflammatory (NSAIDs), aspirin, proton pump inhibitor (PPIs), H2 blocker and antacid in the past 7 days;
- Contraindication to the use of NSAIDs or PPIs;
- Renal or hepatic impairment;
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 |
|---|---|---|
| Nimesulide + Pantoprazole1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo. | Drug | Nimesulide + Pantoprazole |
| Naproxen + EsomeprazoleAlso: VIMOVO1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo. | Drug | Naproxen + Esomeprazole |
Primary outcome
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time frame: 14 days
1 secondary outcome
Incidence of adverse events and dyspeptic complaints during the study
Time frame: 14 days
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 17 Apr 2019.
- Results publication: PubMed 30233140Scheinberg M, Pott Junior H, Macedo EA, Bocchi de Oliveira MF, Ecclissato C, Amazonas RB. Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms. Drug Des Devel Ther. 2018 Sep 6;12:2775-2783. doi: 10.2147/DDDT.S172068. eCollection 2018.
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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.
Pedro A. Petersen, MD principal investigator
Allergisa Pesquisa Dermato-Cosmetica LTDA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimesulide + Pantoprazole and Naproxen + Esomeprazole in people with Acute and Chronic Inflammation and Dyspepsia, run by EMS at 1 site in Brazil.
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 3 inclusion and 5 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. 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?
Comparison relieve pain in patients with osteoarticular diseases and dyspeptic symptoms, defined as visual analogue scale (VAS) version modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). (time frame: 14 days). 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 NCT01670552, which also lists 1 linked publication.
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 17 Apr 2019.