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Trial record 70 of 272 for:    Betamethasone

"Corticoid-16" in Long Term When Administered Systemically in Patients in Routine Medical Practice

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ClinicalTrials.gov Identifier: NCT03119454
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
Institute of Biomedical Chemistry, Russia
The League of Clinical Research, Russia
Information provided by (Responsible Party):
Federal State Budgetary Scientific Institution, Scientific Research Institute of Rheumatology

Brief Summary:

Evaluation of pharmacokinetic parameters of diprospan in long term when administered systemically in patients in routine medical practice.

Applied research project.

Design: open-comparative prospective cohort study.

Two groups of subjects:

  • patients who are receiving diprospan in standard therapy of their existing disease, or multiple times, but following the introduction of diprospan is planned no earlier than 28 days after the first,
  • control group of subjects for the study of pharmacokinetic parameters diprospan and its metabolites.

Objectives of the study: to evaluate the pharmacokinetic parameters of Diprospan in the long term when administered systemically in patients in routine practice.


Condition or disease Intervention/treatment
Pharmacological Action Drug: Diprospan

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Evaluation of Pharmacokinetic Parameters of "Diprospan"
Study Start Date : October 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients receiving diprospan
Patients who are receiving diprospan in standard therapy of their existing disease, or multiple times, but following the introduction of diprospan is planned no earlier than 28 days after the first administration.
Drug: Diprospan
Intramuscular
Other Name: Betamethasone

Control subjects
Patients or healthy volunteers who had not received systemic or local corticosteroids in the last 12 weeks before the screening visit.



Primary Outcome Measures :
  1. Betamethasone concentration in urine [ Time Frame: Day 28 ]
    Quantitative determination of study drug (betamethasone) in human urine should be conducted sensitive, selective and precise method using high performance liquid chromatography with tandem mass selective detection (HPLC-MS / MS) with a detection mode permits fragment ions not more R <70K. laboratory analytical method should be developed for the measurement of betamethasone with the definition of the limit of not less than 7.5 ng / mL.


Secondary Outcome Measures :
  1. Articular status (swelling) [ Time Frame: Day 28 ]
    Number of swollen joints

  2. Articular status (pain) [ Time Frame: Day 28 ]
    Number of painful joints

  3. Physician's assessment of disease activity [ Time Frame: Day 28 ]
    Visual analogue scale, mm

  4. Simple disease activity index SDAI [ Time Frame: Day 28 ]
    Scale: remission; low activity; moderate activity; high activity

  5. Clinical disease activity index CDAI [ Time Frame: Day 28 ]
    Scale: remission; low activity; moderate activity; high activity

  6. Disease activity score DAS28 [ Time Frame: Day 28 ]
    Scale: remission; low activity; moderate activity; high activity


Other Outcome Measures:
  1. Overall assessment of the health status of the patient by physician [ Time Frame: Day 28 ]
    Vital signs, physical examination, new diagnoses

  2. Overall assessment of the health status of the patient by patient [ Time Frame: Day 28 ]
    Visual analogue scale, mm


Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients of both sexes aged 18 to 35 years old Caucasian,

  • verified diagnosis of rheumatoid arthritis according to criteria ACR \ EULAR 2010 or ankylosing spondylitis (axial spondyloarthritis) ASAS criteria for 2009 based on the data a detailed medical history, a standard clinical, laboratory and instrumental methods of examination.
Criteria

Inclusion Criteria:

  • Signed a voluntary informed consent form,
  • Patients of both sexes aged 18 to 35 years old Caucasian,
  • Verified diagnosis of rheumatoid arthritis according to criteria ACR \ EULAR 2010 or ankylosing spondylitis (axial spondyloarthritis) ASAS criteria for 2009 based on the data a detailed medical history, a standard clinical, laboratory and instrumental methods of examination,
  • The presence of signs of active inflammation according to standard valuation techniques (for rheumatoid arthritis or DAS28 ≥3.2 CDAI≥10; for ankylosing spondylitis or BASDAI≥2.0 ASDAS≥1.3),
  • If the patient gets authorized for use in the study antirheumatic drugs (except glucocorticoids other) for treatment of the underlying disease, they should be applied in stable doses for at least six weeks before the screening visit.
  • BMI should be in the range of 18.0 to 30.0 kg / m 2 ,
  • Consent to use adequate methods of contraception to patients during the study period.

Exclusion Criteria:

  • Allergic history,
  • Drug intolerance, hypersensitivity to any of the components "Diprospan" drug,
  • Severe chronic cardiovascular, bronchopulmonary, endocrine and nervous systems (including mental) and diseases of the gastrointestinal tract (GIT), liver, kidney, blood, surgical procedures on the gastrointestinal tract (except appendectomy)
  • Acute infectious, non-infectious and allergic diseases in less than 4 weeks prior to visit 1,
  • A positive blood test for HIV, syphilis, hepatitis B and C,
  • Systolic blood pressure measured at rest after 5 minutes of exposure in the "sitting" position, below 100 mm Hg. or above 140 mm Hg and / or diastolic blood pressure below 60 mm Hg or above 90 mm Hg,
  • Heart rate below 40 beats / min,
  • Hemoglobin <90 g / l (9 g / dl), or hematocrit less than 30%,
  • White blood cells <3.0 x 10 9 / L,
  • Absolute neutrophil count (ANC) <1.0 x 10 / L,
  • Serum creatinine more than 0.132 mmol / L,
  • Increased ALT and / or AST 1.5 upper limit of normal,
  • Clinically significant (in the opinion of the investigator) ECG changes,
  • The use of systemic or local corticosteroids for the treatment of the underlying disease for the last 12 weeks before the screening visit,
  • Taking any medications, in addition to permissible under study
  • Plasmapheresis in less than 14 days prior to study entry,
  • Participation in a clinical trial of an unregistered in the Russian Federation of a drug or device for less than 3 months prior to the study,
  • The inability or unwillingness of the patient to comply with the conditions of the study program,
  • Any reason for that, according to the researcher, will prevent the participation of the patient in the study,
  • Pregnant or lactating women (all women should have a negative pregnancy test on the day of screening).

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Federal State Budgetary Scientific Institution, Scientific Research Institute of Rheumatology
ClinicalTrials.gov Identifier: NCT03119454     History of Changes
Other Study ID Numbers: RU-FANO-10-16
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Betamethasone
Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents