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Effect of Some Drugs on Rheumatoid Arithritis Activity

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770923
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Effect of Some Drugs on Rheumatoid Arithritis Activity.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Rupatadine Drug: Montelukast Phase 3

Detailed Description:
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arms and Interventions
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Arm Intervention/treatment
No Intervention: No intervention
No intervention
Active Comparator: Rupatadine
Rupatadine 10 mg once daily.
 Drug: Rupatadine
Rupatadine 10 mg daily
Active Comparator: Montelukast
Montelukast 10 mg daily
 Drug: Montelukast
Montelukast 10 mg daily


Outcome Measures
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Primary Outcome Measures :
  1. se level of IL-17 [ Time Frame: 6 months ]
    change in level of IL-17


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • liver or renal disease
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03770923


Contacts
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Contact: Sherief Abd-Elsalam, Ph D 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt, 35111
Contact: Fedaa Kotkata, Msc         
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Sahar k Hegazy, Prof Head of Clinical Pharmacy Department
Study Director: Tarek M Mostafa, Prof Clinical pharmacy Department- Tanta University
Study Chair: Salwa E Abd El-Ghany, Prof Rheumatology Dept. - Tanta University
Study Chair: Fedaa AK Kotkata, Msc Clinical pharmacy Department-Tanta University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03770923    
Other Study ID Numbers: Rheumatoid Arithritis
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Montelukast
 Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action