Knee OsteoarthritisAGATANCT02865161
Amtolmetin Gaucil in Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Dr. Reddy's Laboratories Limited.
Trial summary
This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- NISELAT
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- Phase
- Observational
- 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
Study population: Subjects with knee osteoarthrosis (KOA)
Who may be able to join
- Informed consent form for participation in the study;
- KOA (based on ACR, 1987)
- Age between 30-60 years old
- Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)
- Dyspeptic symptoms (according to SODA questionnaire)
- Pain intensity in the investigated knee joint ≥ 40 mm according to VAS
- Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.
Who cannot join
- Contraindications to amtolmetin guacil (according to patient information leaflet)
- Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg
- Signs of renal or hepatic failure;
- Pregnancy, lactation or planning for pregnancy.
- One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.
About this study
Official title: Open-label, Multicenter, Observational (Non-interventional) Study of Efficacy and Tolerability of Amtolmetin GuAcil in Subjects With Knee osTeoArthrosis With Dyspepsia. (AGATA)
This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.
Read the detailed description
Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable.
Amtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.
- Conditions
- Knee Osteoarthritis
- Being tested
- NISELAT
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NISELATDrug
Also called AMTOLMETIN GAUCIL
NISELAT 600MG BD
| Study group | Role | What they receive |
|---|---|---|
| NISELAT | Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg Receives: Drug: NISELAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in WOMAC score from baseline
Reduced WOMAC (according to pain, rigidity and function scales) by > 20 % vs. baseline.
Measured: Baseline to 4 weeks
Secondary outcomes (3)
Change in VAS
Measured: Baseline to 45 weeks
SODA Questionnaire
Measured: Baseline to 4weeks
No of adverse events
Total number of adverse events
Measured: Baseline to 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denisov L Nikolaevich, MD, Principal investigator, Moscow, Federal State Budget Scientific Institution "Scientific Research Institute of Rheumatology named VA Nasonova"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865161
- Sponsor's protocol ID
- NISELAT-AGATA 2014
- Acronym
- AGATA
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Under review
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Observational (Non-interventional) Study of Efficacy and Tolerability of Amtolmetin GuAcil in Subjects With Knee osTeoArthrosis With Dyspepsia. (AGATA)
- ClinicalTrials.gov ID
- NCT02865161
- Acronym / sponsor ID
- AGATA / NISELAT-AGATA 2014
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Aug 2016 (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.
This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.
Detailed description
Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is characterized by high prevalence, progressive course with early disability of the subject, persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal toxicity with efficacy adequate to suppress joint pain is justified and reasonable.
Amtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability of amtolmetin guacil, it is first necessary to obtain data on potential reduction of dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NISELAT | – | Drug: NISELATAmtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with knee osteoarthrosis (KOA)
Key inclusion criteria (7 listed)
- Informed consent form for participation in the study;
- KOA (based on ACR, 1987)
- Age between 30-60 years old
- Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)
- Dyspeptic symptoms (according to SODA questionnaire)
Key exclusion criteria (5 listed)
- Contraindications to amtolmetin guacil (according to patient information leaflet)
- Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg
- Signs of renal or hepatic failure;
- Pregnancy, lactation or planning for pregnancy.
- One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.
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 |
|---|---|---|
| NISELATAlso: AMTOLMETIN GAUCILNISELAT 600MG BD | Drug | NISELAT |
Primary outcome
Reduction in WOMAC score from baseline
Time frame: Baseline to 4 weeks
Reduced WOMAC (according to pain, rigidity and function scales) by > 20 % vs. baseline.
3 secondary outcomes
Change in VAS
Time frame: Baseline to 45 weeks
SODA Questionnaire
Time frame: Baseline to 4weeks
No of adverse events
Time frame: Baseline to 4 week
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 30 Sep 2016.
- Individual participant dataSharing planned: Undecided. Under review
Related trials for Knee Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Denisov L Nikolaevich, MD principal investigator
Moscow, Federal State Budget Scientific Institution "Scientific Research Institute of Rheumatology named VA Nasonova"
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Dr. Reddy's Laboratories Limited.
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 7 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 30 Sep 2016. 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.
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?
Reduction in WOMAC score from baseline (time frame: Baseline to 4 weeks). 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 30 Sep 2016.