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Amtolmetin Gaucil in Knee Osteoarthritis (AGATA)

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Locations

Study Type

Observational

Intervention

NISELAT

About this trial

This is an observational trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Arm Label

NISELAT

Arm Description

Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg

Outcomes

Primary Outcome Measures

Reduction in WOMAC score from baseline

Reduced WOMAC (according to pain, rigidity and function scales) by > 20 % vs. baseline.

Secondary Outcome Measures

Change in VAS

SODA Questionnaire

No of adverse events

Total number of adverse events

Full Information

NCT ID

NCT02865161

First Posted

August 11, 2016

Last Updated

September 29, 2016

Sponsor

Dr. Reddy's Laboratories Limited

1. Study Identification

Unique Protocol Identification Number

NCT02865161

Brief Title

Amtolmetin Gaucil in Knee Osteoarthritis

Acronym

AGATA

Official Title

Open-label, Multicenter, Observational (Non-interventional) Study of Efficacy and Tolerability of Amtolmetin GuAcil in Subjects With Knee osTeoArthrosis With Dyspepsia. (AGATA)

Study Type

Observational

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Reddy's Laboratories Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NISELAT

Arm Description

Amtolmetin guacil should be taken in fasting conditions. The recommended dose is 600 mg b.i.d. Maximum daily dose - 1800 mg

Intervention Type

Drug

Intervention Name(s)

NISELAT

Other Intervention Name(s)

AMTOLMETIN GAUCIL

Intervention Description

NISELAT 600MG BD

Primary Outcome Measure Information:

Title

Reduction in WOMAC score from baseline

Description

Reduced WOMAC (according to pain, rigidity and function scales) by > 20 % vs. baseline.

Time Frame

Baseline to 4 weeks

Secondary Outcome Measure Information:

Title

Change in VAS

Time Frame

Baseline to 45 weeks

Title

SODA Questionnaire

Time Frame

Baseline to 4weeks

Title

No of adverse events

Description

Total number of adverse events

Time Frame

Baseline to 4 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Study Population Description

Subjects with knee osteoarthrosis (KOA)

Sampling Method

Non-Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Denisov L Nikolaevich, MD

Organizational Affiliation

Moscow, Federal State Budget Scientific Institution "Scientific Research Institute of Rheumatology named VA Nasonova"

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Under review

Learn more about this trial

Amtolmetin Gaucil in Knee Osteoarthritis

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