Obstructive Sleep Apnea Syndrome
Conditions
Interventions
Product Name: Dexloxiglumide
Product Code: CR2017
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DEXLOXIGLUMIDE
CAS Number: 119817-90-2
Current Sponsor code: CR2017
Concentration unit: mg mil
Sponsors
Rottapharm S.p.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Signed and dated informed consent obtained before undergoing any trial-specific procedure 2.Male patients aged between 30 and 60 years. 3.Patients with medically uncomplicated OSA (diagnosed according to American Academy of Sleep Medicine guideline). 4.Patients naïve to any form of treatment [Behavioral, Oral Appliances, Surgical, Adjunctive, continuous (CPAP), bi-level (BPAP), or autotitrating (APAP) Positive Airway Pressure]. 5.Patients with Apnea-Hypopnea Index (AHI) = 30. 6.Patients able to communicate, participate and comply with the requirements of the entire study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients with arterial oxygen saturation 5% of total sleep time, based on screening ambulatory monitoring. 2.Patients with Body Mass Index (BMI) =32. 3.History of rotating or permanent night shift work within 6 months. 4.Significant cardiovascular (except controlled arterial hypertension), endocrine, hematologic, metabolic, neurologic (including epilepsy), psychiatric, pulmonary, renal disorder, or sleep disorder other than obstructive sleep apnea (OSA), documented by physical or laboratory examination or by medical history. 5.Patients with any abnormality in ECG, vital signs or laboratory determination judged clinically significant by the investigator. 6.Patients with a history of drug, alcohol or other abuse substance or other factors limiting their ability to co-operate during the study. 7.Patients with known hypersensitivity to any of the test materials 8.Patients who were already taking other investigational drugs/treatments, or who had taken part in a clinical study within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether CR2945 or CR2017 are an effective treatment in patients with obstructive sleep apnea;Secondary Objective: To assess CR2945 and CR2017 safety and tolerability in patients with obstructive sleep apnea;Primary end point(s): AHI reduction at the end of each study treatment, compared to the relevant baseline;Timepoint(s) of evaluation of this end point: end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •% of patients with AHI reduction of at least 35% at the end of each study treatment, compared to the relevant baseline. •% of patients with AHI less than 10/h at the end of each study treatment. •% of patients with reduction of ODI of at least 35% at the end of each treatment compared to the relevant baseline. •ODI reduction at the end of each study treatment, compared to the relevant baseline ;Timepoint(s) of evaluation of this end point: end of treatment | — |
Countries
Italy
Contacts
Public ContactMedical Director
Rottapharm S.p.A.
Outcome results
None listed