Amtolmetin Gaucil in Knee Osteoarthritis

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: NISELAT

• Registration Number: NCT02865161
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Informed consent form for participation in the study;
2. KOA (based on ACR, 1987)
3. Age between 30-60 years old
4. Previous regular administration of NSAIDs for at least 4 weeks (at maximum therapeutic dose)
5. Dyspeptic symptoms (according to SODA questionnaire)
6. Pain intensity in the investigated knee joint ≥ 40 mm according to VAS
7. Subjects with systolic blood pressure ≤ 140 mm Hg and diastolic BP ≤90 mmHg against stable antihypertensive therapy.

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Exclusion Criteria

1. Contraindications to amtolmetin guacil (according to patient information leaflet)
2. Subjects with SBP ≥140 mm Hg and DBP ≥90 mm Hg
3. Signs of renal or hepatic failure;
4. Pregnancy, lactation or planning for pregnancy.
5. One of the following changes in laboratory values at screening HGB, WBC, ESR, ALT, AST.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reduction in WOMAC score from baseline	Baseline to 4 weeks	Reduced WOMAC (according to pain, rigidity and function scales) by \> 20 % vs. baseline.

Secondary Outcome Measures

Name	Time	Method
No of adverse events	Baseline to 4 week	Total number of adverse events
Change in VAS	Baseline to 45 weeks
SODA Questionnaire	Baseline to 4weeks