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Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.

NCT01117948 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2013-02-06

Study results available
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Summary

Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate probable Alzheimer's Disease.

Study phase: II

Indication: Alzheimer´s Disease

Investigational product, dose schedule and route of administration: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Conditions

  • Alzheimer´s Disease

Interventions

DRUG

Lornoxicam

Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

DRUG

Placebo

Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Sponsors & Collaborators

  • JSW Lifesciences

    lead OTHER

Principal Investigators

  • Elisabeth Sterner, M.Sc. · JSW-Life Sciences

  • Reinhold Schmidt, MD

  • Michael Rainer, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-04-30
Completion
2011-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01117948 on ClinicalTrials.gov