AzTrials
AzTrials

AnxietyPhase 3NCT05586789

A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

A Phase 3 study testing Ranquilon in people with Anxiety and Neurasthenia, run by Valenta Pharm JSC at 10 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anxiety, Neurasthenia, Adjustment Disorders
What is being tested?
Ranquilon
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
10 sitesRussia
Study dates
12 Oct 2022to 3 Jan 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women between the ages of 18 and 70
  • Presence of written consent to participate in the study in accordance with applicable law
  • Patients with anxiety and diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2)
  • HARS anxiety scores of 18-24
  • Severity of asthenia on the Asthenia Self Assessment Scale (MFI-20) of more than 50 points
  • Hamilton Depression Assessment Scale (HAMD-17) score < 6
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  • CGI-s scale score of at least 4
  • Negative pregnancy test for women of preserved reproductive potential
  • Consent to use effective contraception for the duration of the study and 30 days after completion (for women of unresolved reproductive potential and men)
  • Ability to understand the requirements for study participants, to give written consent to participate in the study (including the use and communication of patient health information relevant to the study) and to comply with the procedures of the study protocol

Who cannot join

  • Known intolerance to the active ingredient and/or excipients in the study drug/placebo of the study drug
  • Known presence of lactase deficiency, lactose intolerance, glucose-galactose malabsorption or galactose intolerance
  • Patients who require concomitant therapy prohibited in this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), sleeping pills when used on a continuous basis), or have taken these drugs within the last month
  • Established or suspected alcohol/drug use at the time of screening or randomization, and/or a history of alcohol, drug or drug dependence
  • Presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years)
  • Presence of tuberculosis, including a history of tuberculosis
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  • The presence of HIV, chronic viral hepatitis B/C, syphilis (including a history), or a positive test for HIV, hepatitis B/C, syphilis at screening
  • Patients with a diagnosis established on the basis of ICD-10 criteria: other anxiety disorders (F41)
  • Schizophrenia, schizoaffective, affective and panic disorders
  • Acute psychosis (endogenous-procedural, organic or somatogenic), including history
  • Organic lesions of the central nervous system of traumatic and alcoholic genesis
  • Postencephalitic syndrome
  • Brain tumors, including in the anamnesis
  • Degenerative diseases of the central nervous system (CNS), in particular, multiple sclerosis
  • Depression, including a history of depression
  • Generalized anxiety disorder, including a history
  • Suicidal thoughts or ideas; a history of suicide attempts
  • Epilepsy, seizures, including a history of seizures
  • Diabetes mellitus at the stage of decompensation
  • Established diagnosis of chronic kidney disease stage 3A or higher, or glomerular filtration rate (GFR) calculated by the Cockcroft-Gault formula = 59 ml/min/1.73 m2 or less
  • Established diagnosis of hepatic failure of any severity, or elevated ALT, AST or total bilirubin, urea >3 times the upper limit of normal values
  • Conditions after major surgical interventions, if less than six months have elapsed since the intervention
  • Chronic heart failure New York Heart Association (NYHA) functional class III-IV
  • Severe, decompensated, or unstable disease (any disease or condition that threatens the patient's life or worsens the patient's prognosis, or makes it impossible to perform a clinical trial in the patient)
  • Pregnant women, women breastfeeding, or women planning to become pregnant during the study and 30 days after study participation ends
  • Refusal by the patient to use approved contraception or to completely abstain from sexual intercourse during the entire period of study participation, beginning at Visit 0, and for 30 days after completion of study participation
  • Patient's current or planned participation in psychological or psychotherapeutic interventions designed to treat an anxiety disorder during the course of the clinical trial
  • Participation in any other clinical trial within 90 days prior to the screening period
  • Lack of willingness to cooperate on the part of the patient
  • Other reasons that, in the opinion of the investigator, prevent the patient from participating in the study or pose an unreasonable risk to the patient
  • Withdrawal Criteria:
  • Patient's desire to stop participating in the study (withdrawal of informed consent) Each patient has the right to stop participating in the study at any time without giving a reason. Withdrawal from the study will not affect the medical care provided to the patient in the future.
  • A decision by the research physician that the patient should be excluded is in the patient's own best interest
  • Patient refuses to cooperate with the investigator or is undisciplined
  • Causes/occurrence of situations during the study that threaten patient safety (e.g., hypersensitivity reactions, SAE, etc.)
  • Inclusion of a patient in the study with inclusion/inclusion criteria not met (prior to randomization)
  • Significant violation of the treatment regimen A significant violation is defined as a) skipping study drug/placebo for 2 consecutive full days or more, or b) taking, in total, < 80% or >120% of the full course (full course = 168 pills)
  • Positive pregnancy test
  • Confirmed diagnosis of COVID-19
  • Occurrence in the course of the study of other reasons that prevent the study according to the protocol
  • Death of a patient

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Russia10 sites

  • Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region

    Engel's, 413090

  • State Budgetary Health Institution of Nizhny Novgorod Oblast "Clinical Psychiatric Hospital No. 1 of Nizhny Novgorod. Nizhny Novgorod"

    Nizhny Novgorod, 603155

  • Professors' Clinic LLC.

    Perm, 614070

  • Limited Liability Company "Research Center Eco-Security"

    Saint Petersburg, 191119

  • EosMED JSC

    Saint Petersburg, 194000

  • Limited Liability Company "Energy of Health"

    Saint Petersburg, 194156

  • LLC "Aurora MedFort"

    Saint Petersburg, 194156

  • Limited Liability Company "Research Center Eco-Safety"

    Saint Petersburg, 196143

  • Limited Liability Company "Meili"

    Saint Petersburg, 199406

  • Saratov City Psychoneurological Dispensary

    Saratov, 410038

Other trials in Russia

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Phase III Clinical Trial to Examine the Clinical Efficacy and Safety of Ranquilon, 1 mg Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder.

An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.

Being tested
Ranquilon, Placebo
Medical subject headings
Anxiety Disorders, Neurasthenia, Adjustment Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanquilonDrug

    Also called GB-115, 6-phenylhexanoyl)glycyl-L-tryptophan amide

    Two 1 mg tablets 3 times per day for 28 days

  • PlaceboDrug

    Two tablets 3 times per day for 28 days

Study groups in NCT05586789
Study groupRoleWhat they receive
RanquilonExperimentalStudy drug Ranquilon, tablets, 1 mg, 2 tablets 3 times a day (daily dose - 6 mg/day), daily, for 28 days
Receives: Drug: Ranquilon
PlaceboPlacebo comparatorPlacebo, tablets, 2 tablets 3 times a day, daily, for 28 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 ± 1

    HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.

    Measured: Day 29 ± 1 of the study

Secondary outcomes (60)

  1. Proportion of patients with a significant, i.e., 50% or greater reduction in HARS anxiety level on Day 15 ± 1 (Visit 2)

    HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.

    Measured: Day 15 ± 1 of the study

  2. Change in HARS anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline

    HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  3. Proportion of patients with HARS anxiety scores reduced to 17 or less on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)

    HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  4. Time to decrease the HARS anxiety level to a score of 17 or less

    HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.

    Measured: Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first

  5. Proportion of patients with significant and marked improvement as assessed by the physician (Clinical Global Impression - improvement (CGI-i) score 1 or 2) at Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)

    The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  6. Proportion of patients with a CGI-s score of 1 or 2 as assessed by the physician (healthy or borderline disorder) on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)

    The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  7. Time to significant or marked improvement - achieving a score of 1 or 2 on the CGI-i scale

    The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)

    Measured: Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first

  8. Time to decrease in severity of condition to 2 points or to 1 point or CGI-s scale

    The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)

    Measured: Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first

  9. Absolute value of the patient's CGI-i score by Days 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3)

    The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  10. Change in patient severity on the CGI-s scale by Days 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3) compared to baseline

    The Clinical Global Impression Scale (CGI) includes two subscales: one for severity of symptoms and one for progression of symptoms with treatment. The first subscale is called Clinical Global Impression - severity (CGI-s) and the second subscale is Clinical Global Impression - improvement (CGI-i). CGI-s includes scores from 0 (healthy) to 7 (very severe); CGI-i includes scores from 1 (marked improvement) to 7 (marked deterioration)

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  11. Change in the Multidimensional Fatigue Fatigue Inventory (MFI-20) total score on Day 15 ± 1 (Visit 2) and 29 ± 1 (Visit 3) compared to baseline

    The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome

    Measured: Day 15 ± 1 and Day 29 ± 1 of the study

  12. Time to decrease the MFI-20 cumulative score to 30 points or less

    The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome

    Measured: Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first

  13. Time to decrease the MFI-20 cumulative score by 25% and 50% from baseline

    The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome

    Measured: Screening, Day 15 ± 1, Day 29 ± 1 of the study, or an early termination visit, whichever came first

  14. Proportion of patients with a 25% reduction in MFI-20 total score on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) from baseline

    The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome

    Measured: Day 15 ± 1 and Day 29 ± 1

  15. Proportion of patients with a 50% reduction in MFI-20 total score on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) from baseline

    The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome

    Measured: Day 15 ± 1 and Day 29 ± 1

  16. Proportion of patients with a decrease in their MFI-20 cumulative score to 30 on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)

    The Multidimensional Fatigue Fatigue Inventory (MFI-20) provides a subjective quantitative assessment of the overall severity of asthenia and its various aspects. This scale consists of 20 items reflecting the main components of asthenic syndrome, such as: general asthenia, physical asthenia, mental asthenia, decreased activity and decreased motivation. The patient was given an opportunity to rate the mentioned items to his/her condition on a five-point scale. The score of the scale is the sum of the points of its individual constituent items and can vary in the range from 5 to 25 points. Normally, the total number of points should not exceed 30. If the total score on one of the subscales was higher than 12, this could be a preliminary ground for classifying the condition as an asthenic syndrome

    Measured: Day 15 ± 1 and Day 29 ± 1

  17. Change in Spielberger personality anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline

    The Spielberger Questionnaire includes a series of statements describing personal and situational anxiety, the answers to which are scored from 1 (least severe or prolonged) to 4 (most severe or prolonged). The patient reads the statements and independently chooses the most appropriate frequency for each statement. When analyzing the results of the self-assessment, you should keep in mind that the overall total for each of the subscales may range from 20 to 80 points. The higher the total score, the higher the level of anxiety (situational or personal).

    Measured: Day 15 ± 1 and Day 29 ± 1

  18. Change in situational anxiety levels on the Spielberger questionnaire on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline

    The Spielberger Questionnaire includes a series of statements describing personal and situational anxiety, the answers to which are scored from 1 (least severe or prolonged) to 4 (most severe or prolonged). The patient reads the statements and independently chooses the most appropriate frequency for each statement. When analyzing the results of the self-assessment, you should keep in mind that the overall total for each of the subscales may range from 20 to 80 points. The higher the total score, the higher the level of anxiety (situational or personal).

    Measured: Day 15 ± 1 and Day 29 ± 1

  19. Safety and Tolerability: adverse event (AE) rate

    Number and frequency of adverse events (AEs) or serious AEs (SAEs)

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant

  20. Safety and Tolerability: AEs associated with the study drug

    Number and frequency of AEs or SAEs associated with the study drug

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant

  21. Safety and Tolerability: treatment discontinuation

    Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 44 ± 1 for each participant

  22. Safety and Tolerability: vital signs - systolic blood pressure (SBP)

    SBP, mmHg

    Measured: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation

  23. Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

    DBP, mmHg

    Measured: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation

  24. Safety and Tolerability: vital signs - respiratory rate (RR)

    RR, breaths per minute

    Measured: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation

  25. Safety and Tolerability: vital signs - heart rate (HR)

    HR, beats per minute

    Measured: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation

  26. Safety and Tolerability: vital signs - body temperature

    Body temperature, centigrade scale

    Measured: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation

  27. Safety and Tolerability: physical examination results

    Physical examination will follow the general rules of internal medicine: general examination, examination of mucous membranes and skin, including palpation of lymph nodes, evaluation of the musculoskeletal system, palpation, percussion, and auscultation of the main organ systems (cardiovascular, respiratory, digestive, and urinary systems) will be performed sequentially

    Measured: Screening, day 1, day 15, day 29, and day 44 of the study or on the early termination visit, whichever came first, within 44 days of study participation

  28. Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: heart rate (beats per minute)

    Measured: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation

  29. Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: PQ interval (ms)

    Measured: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation

  30. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QRS complex (ms)

    Measured: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation

  31. Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval (QTc)

    12-lead ECG (I, II, III, aVR, aVL, aVF, V1-V6) taken while lying down: QTc (ms)

    Measured: Screening, day 29, or on the early termination visit, whichever came first, within 44 days of study participation

  32. Safety and Tolerability: complete blood count - hemoglobin

    Hemoglobin, g/dL

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  33. Safety and Tolerability: complete blood count - hematocrit

    Hematocrit, %

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  34. Safety and Tolerability: complete blood count - red blood cells

    Red blood cells, 10^6/uL

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  35. Safety and Tolerability: complete blood count - white blood cells

    White blood cells, 10^3/uL

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  36. Safety and Tolerability: complete blood count - platelets

    Platelets, 10^3/uL

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  37. Safety and Tolerability: complete blood count - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate, mm per hour

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  38. Safety and Tolerability: complete blood count - lymphocytes

    Lymphocytes, %

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  39. Safety and Tolerability: complete blood count - eosinophils

    Eosinophils, %

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  40. Safety and Tolerability: complete blood count - monocytes

    Monocytes, %

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  41. Safety and Tolerability: complete blood count - basophils

    Basophils, %

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  42. Safety and Tolerability: complete blood count - neutrophils

    Neutrophils, % (segmented and stab)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  43. Safety and Tolerability: blood test results - total cholesterol

    Total cholesterol in blood serum, mmol/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  44. Safety and Tolerability: blood test results - total protein

    Total protein in blood serum, g/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  45. Safety and Tolerability: blood test results - glucose

    Glucose in blood serum, mmol/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  46. Safety and Tolerability: blood test results - creatinine

    Creatinine in blood serum, umol/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  47. Safety and Tolerability: blood test results - alanine transaminase (ALT)

    ALT in blood serum, U/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  48. Safety and Tolerability: blood test results - aspartate transaminase (AST)

    AST in blood serum, U/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  49. Safety and Tolerability: blood test results - total bilirubin

    Total bilirubin in blood serum, umol/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  50. Safety and Tolerability: blood test results - direct bilirubin

    Direct bilirubin in blood serum, umol/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  51. Safety and Tolerability: blood test results - alkaline phosphatase (ALP)

    ALP in blood serum, U/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  52. Safety and Tolerability: blood test results - urea

    Urea in blood serum, mmol/L

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  53. Safety and Tolerability: urinalysis - color

    Color of the urine (yellow, brown, etc.)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  54. Safety and Tolerability: urinalysis - transparency

    Transparency of the urine (transparent/cloudy)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  55. Safety and Tolerability: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  56. Safety and Tolerability: urinalysis - pH

    pH of the urine

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  57. Safety and Tolerability: urinalysis - glucose

    Glucose in the urine (mmol/L)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  58. Safety and Tolerability: urinalysis - protein

    Protein in the urine (g/L)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  59. Safety and Tolerability: urinalysis - ketones

    Ketones in the urine (mmol/L)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

  60. Safety and Tolerability: urinalysis - urobilinogen

    Urobilinogen in the urine (umol/L)

    Measured: Screening, Day 29 or the early termination visit, whichever came first, within 44 days of study participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start12 Oct 2022
  3. Primary completion22 Nov 2022
  4. Study completion3 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586789
Sponsor's protocol ID
RAN-03-03-2022
Status last verified
Jul 2023
First submitted
14 Oct 2022
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranquilon in people with Anxiety and Neurasthenia, run by Valenta Pharm JSC at 10 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 ± 1 (time frame: Day 29 ± 1 of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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