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Clinical Trials/NCT00144859
NCT00144859
Completed
Phase 2

A 28-day, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 7.5 mg Per Day in Patients With Chronic Obstructive Pulmonary Disease.

GlaxoSmithKline1 site in 1 country82 target enrollmentJuly 2005
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ConditionsPulmonary Disease, Chronic ObstructiveChronic Obstructive Pulmonary Disease (COPD)
DrugsSB681323

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pulmonary Disease, Chronic Obstructive
Sponsor
GlaxoSmithKline
Enrollment
82
Locations
1
Primary Endpoint
Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).

Registry
clinicaltrials.gov
Start Date
July 2005
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)

Secondary Outcomes

  • Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics

Study Sites (1)

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