None listed
Conditions
Interventions
Group 1 Type of group
One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
Group name:Group 3 Type of group
One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female> 18 to <75 years of age on the day of signing the informed consent. • The patient understands the study procedures, the available alternative treatments, the risks involved in the study and voluntarily agrees to participate by signing an informed written consent. • The patient is male or female with a low probability of conceiving
Exclusion criteria
Exclusion criteria: • The patient is pregnant, breastfeeding or expecting to conceive during the study including follow-up at 14 days after the study. • The patient has a history of malignant neoplasms <5 years before signing the informed consent, except for basal cell or squamous cell skin cancer or cervical cancer in situ properly treated. • The female patient is waiting to donate eggs during the study, including follow-up at 14 days or a male patient expects to donate sperm during the study, including follow-up at 14 days. • The patient has a history or current evidence of laboratory conditions, treatment or abnormalities that could confuse the results of the study, interfere with the patient´s participation during the entire period of the study, or do not keep the best interests for the patient´s participation. • The patient is unlikely to comply with the study procedures, keep appointments or are planning to move during the study. • The patient currently participates or has participated in a study with a research compound (non-lipid modification) in a period of 30 days before Visit 1, or a lipid modification compound (in research or commercialized) in a period of 6 weeks before Visit 1. • The patient has donated and / or received blood • At the time of signing the informed consent, the patient is a consumer of recreational or illegal drugs or has had a recent history (last year) of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Flushing symptoms were recorded using participants response to the Global Flushing Severity Score (GFSS), which assessed the overall severity of the flushing experience, using a scale of 0 (no symptom) to 10 (extreme). The number of days/week was derived as: 7*(total number of days with GFSS ≥4 across Weeks 21-32 divided by the total number of days with nonmissing GFSS across the same period). The number of days/week with a GFSS ≥4 for each participant was listed in 1 of the following 6 categories: 0, >0 to 0.5, >0.5 to 1, >1 to 2, >2 to 3, and >3 days per week. Measure:Number Participants With Days Per Week With Global Flushing Severity Score (GFSS) ≥4 Partitioned Into 6 Categories During the Postwithdrawal Period Timepoints:Week 21 to Week 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Flushing symptoms were recorded using participants response to the Global Flushing Severity Score (GFSS), which assesses the overall severity of the flushing experience (including redness, warmth, tingling, or itching) using a scale with response categories of None, Mild, Moderate, Severe, and Extreme. The categories were supplemented with numbers 0 to 10 to allow for greater precision within each category (None=0, Mild=1-3, Moderate=4-6, Severe=7-9, Extreme=10). The daily response was recorded in the morning, and reflected the symptoms experienced during the previous 24 hours. Measure:Number of Participants With Maximum GFSS ≥4 During the Post-withdrawal Period Timepoints:Week 21 to Week 32 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed