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Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00542022
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: MK0812 / Duration of Treatment: 12 Weeks Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients
Study Start Date : June 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
  • Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
  • Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests

Exclusion Criteria:

  • Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
  • Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
  • Female patient is pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00542022

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00542022     History of Changes
Other Study ID Numbers: 0812-008
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents