Drug-Drug Interaction of Cladribine and Pantoprazole in Multiple Sclerosis Subjects

Women left out

• No pregnant women

  Women who were pregnant could not join.

  “Pregnant or nursing women. Treatment of pregnant and nursing women with cladribine in this study was prohibited”

• No breastfeeding moms

  Women who were breastfeeding could not join.

  “Pregnant or nursing women. Treatment of pregnant and nursing women with cladribine in this study was prohibited”

• Had to use birth control

  Women who couldn't or didn't want to use birth control were turned away.

  “…ast two years, surgically or medically sterile or sexually inactive; or willing to avoid pregnancy by using an adequate method of birth control for 28 days prior to, during and up to 90 days after the last administration of trial medication”

• Only women past menopause

  Women who could still get pregnant were turned away.

  “Female subjects lacking childbearing potential defined as post-menopausal for at least two years, surgically or medically sterile or sexually inactive; or willing to avoid pregnancy by using an adequate method of birth control for 28 days p…”

• Weight limit (BMI)

  Women with a higher (or lower) body weight were turned away.

  “Subjects with a body mass index less than or equal to (\<=) 28 and have a body weight greater than (\>) 60 kilogram (kg) and less than (\<) 120 kg, at screening”

• No kidney or liver problems

  Women with kidney or liver problems were turned away.

  “History or presence of hypertension or other significant cardiovascular abnormality, history of heart or kidney disease”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “…betes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, a significant pre-existing hematological disease, or any medical condition, which in the opinion of the investigator, would constitute a risk or…”

• No diabetes

  Women with diabetes were turned away.

  “Subjects presenting a severe or unstable disorder: poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, a significant pre-existing hematological disease, or any medical conditio…”

• No cancer

  Women with current or past cancer were turned away.

  “Current diagnosis or personal history of cancer”

• No smokers

  Women who smoke or use nicotine were turned away.

  “Intake of alcoholic beverages, caffeine and caffeine containing beverages, grapefruit, oranges, cranberries and juices of these three fruits or smoking in the 48 hours prior to first dose and 48 hours post dose (cladribine)”

Study titles and rules are shown in their original English.