NCT02865161

Brief Summary

This study is conducted to study the efficacy and safety of Niselat in patients with osteoarthritis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

September 30, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

August 11, 2016

Last Update Submit

September 29, 2016

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Reduction in WOMAC score from baseline

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

    Baseline to 4 weeks

Secondary Outcomes (3)

  • Change in VAS

    Baseline to 45 weeks

  • SODA Questionnaire

    Baseline to 4weeks

  • No of adverse events

    Baseline to 4 week

Study Arms (1)

NISELAT

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

Drug: NISELAT

Interventions

NISELATDRUG

NISELAT 600MG BD

Also known as: AMTOLMETIN GAUCIL
NISELAT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with knee osteoarthrosis (KOA)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Denisov L Nikolaevich, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 12, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 30, 2016

Record last verified: 2016-08