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Phase II Study of CG100649 for Primary Osteoarthritis in Male Subjects

NCT00530452 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2008-06-13

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and efficacy of 3 loading and maintenance dose levels of CG100649 administered for 21 days in the treatment of osteoarthritis pain.

Conditions

  • Osteoarthritis, Knee
  • Osteoarthritis, Hip

Interventions

DRUG

CG100649

Dual-acting COX-2 inhibitor \& carbonic anhydrase inhibitor in gelatin capsules. Oral loading doses (2, 4, or 8 mg vs. placebo) followed by daily oral maintenance doses (0.3, 0.6, or 1.2 mg vs. placebo) for 20 days (total 21 days therapy).

DRUG

Silicified microcrystalline cellulose + talc

Gelatin capsules containing cellulose/talc matched for weight and color to experimental medication. Placebo administered orally 1x/day.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • William K Schmidt, PhD · CrystalGenomics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Germany

Study Locations

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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 NCT00530452 on ClinicalTrials.gov