Study Treatment. Contractor shall supply and maintain drug kits for administration of the magnesium sulfate.
Study Treatment. Magnesium sulfate (Mg) or matching placebo will be administered intravenously with a 16 minute bolus load followed by a 24 hour infusion. The bolus-loading dose will contain 4 grams Mg in 8 ml normal saline. The maintenance infusion will contain 16 grams Mg diluted in 282ml 0.9% normal saline, infused at 12 ml/hr for 24 hours. Paramedics in the field will initiate the bolus-loading dose, administered by slow intravenous push over 16 minutes. The maintenance infusion will be initiated in hospital immediately upon completion of the loading dose. Drug kits will be specially prepared for the study and carried in each participating vehicle. Each kit will include two syringes preloaded with study agent or placebo, one vial containing study agent or placebo, one bag of 250 ml normal saline, a study information sheet, and two preprinted adhesive labels. The two pre-loaded syringes are for the field dose, and will each contain 2 grams Mg in 4 ml normal saline, or matching placebo. These will be administered directly by the paramedics by slow iv push over 16 minutes, including 8 per syringe. The vial is for the in-hospital maintenance dose, and will contain 16 grams of Mg in 32 ml 0.9% normal saline. Emergency Department nursing personnel will add the contents of the vial to the 250 ml saline bag and infuse the trial solution by intravenous cannula over 24 hours using a controlled rate infusion pump. Each of the ~366 ambulances participating in the study will be stocked with two drug kits at all times, one for under one hour patients and the second for 1-2 hour patients. These kits will be color-coded, with green for under 1 hour patients and yellow for 1-2 hour patients. After each patient enrollment, the vehicle will be restocked on the same or following day. Kits will be stored at 15-30 degrees Centigrade in the pharmacy/central warehouse of the Los Angeles City Fire Department. When stocked in rescue vehicles, kits will be stored at ambient temperature (generally 15-30 degrees Centrigrade) for 12 months. Stability analyses show that magnesium sulfate suffers no significant loss of potency when stored at room temperature for a minimum of 60 months. Kits that expire unused in ambulances after 12 months will be replaced. As soon as a patient is enrolled, the enrolling physician will activate the study nurse at the hospital to which the patient is being transported. The study nurse will travel to the receiving hospital to assist Emergency Department and Hospital nur...
Study Treatment. RIST4721
Study Treatment. Screening Up to 2 months 1-2 None (vitamin D in subjects with low vitamin D at baseline) Pretreatment Up to 2 weeks 1 Vitamin D and calcium Treatment 6 months 8 Vitamin D, calcium, Study Medication Follow-up 1 month 1 Vitamin D and calcium Total 9-10 months 11-12 * For the purposes of this study one month is equal to 30 days. The first self-administration of study medication is to occur at the clinical site under observation. On the days of clinic visits, study medication must be administered in the clinic to accommodate pre- and post-administration procedures. In addition, on days of clinic visits, study personnel will evaluate the application/injection site and patch adhesion (if applicable) using the same scales used by the subject. This information is to be entered into the e-CRF and source documents. Upon the removal of the transdermal patch on the days of clinic visits, the used patch will be carefully replaced into the collar assembly using minimal manipulation and will be frozen (-20ºC) for return to the manufacturer (3M, St. Xxxx MN) for further inspection and analysis (Refer to the study operations manual for detailed instructions). On the days when study medication is administered in the subject’s home, the subject is to dispose of the used patch in a sharps container and maintain the foil pouch for return to the study center for accountability purposes. Subjects randomized to the BA058 Injection arm should bring their used and unused BA058 Injection cartridges to each clinic visit for accountability purposes.
Study Treatment. Treatment Assignment Restrictions During Study Treatment Dose-Limiting Toxicity (DLT) Maximum Tolerated Dose (MTD), and Recommended Phase 2 Dose (RP2D)
Study Treatment. Eligible subjects will receive 56 weeks of treatment with either VI-0521, or matching placebo for daily use.
Study Treatment. The term “study treatment” refers to the study product (see Section 7.1)
7.1 Product Identification and Use Form Opaque ointment Mode of Administration Topical Formula code 1748 Formula number B50H48 Lot numbers 0281N14C Storage and Handling The product is to be stored under controlled room temperature conditions 20°C to 25°C (68°F to 77°F), protected from freezing and sunlight. The ingredient list of the study product is included in Appendix I.
Study Treatment. The term “study treatment” refers to the study products (HA Fillers, see Section 7.1)
7.1 Product Identification and Use Form Transparent gel of HA with the addition of lidocaine hydrochloride 3 mg/mL Mode of Administration Injection How supplied Pre-filled plastic syringes containing 1 mL of gel. Each syringe is co-packed with two ultra-thin wall needles. Lot numbers 19741 Storage and Handling The syringes are to be stored in the original packaging, under controlled room temperature conditions 20°C to 25°C (68°F to 77°F), protected from freezing and sunlight. Form Sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of HA crosslinked with BDDE, formulated to a concentration of 20 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. Mode of Administration Injection How supplied Individual treatment syringes with needles. Lot numbers VB20B20024 Storage and Handling Store at room temperature (up to 25°C/77°F). DO NOT FREEZE.
Study Treatment. The term “study treatment” refers to the study products (see Section 7.1)
7.1 Study product Identification and Use Form Lyophilized PLLA with sodium carboxymethylcellulose, non- pyrogenic mannitol. Mode of administration Injection following reconstitution How supplied Sterile freeze-dried preparation in a clear glass vial, which is sealed by a penetrable stopper, covered by an aluminum seal with a flip-off cap. Lot numbers To be added upon study completion Storage and handling Store under controlled room temperature conditions, up to 30°C (86°F). DO NOT FREEZE. Refrigeration is not required. Form Opaque, sterile, non-pyrogenic, semi-solid, cohesive implant whose component is synthetic CaHA suspended in a gel carrier of glycerin, sodium carboxymethylcellulose, 0.3% lidocaine hydrochloride, and sterile water. Mode of administration Injection How supplied Individual treatment syringe with needle Lot numbers To be added upon study completion Storage and handling Store at controlled room temperature between 15°C and 32°C (59°F and 90°F).
Study Treatment. 7.1 Study supplies Study treatment will be prescribed to the patient as for normal clinical practice
7.2 Study treatment formulation, packaging and storage The most commonly used form of this medication in Italy is Bassado (Pfizer), which will be prescribed to every patient in this study. The active ingredient is doxycycline (as doxycycline hyclate). Each tablet contains 100 mg of doxycycline (equivalent to 115.4 mg of doxycycline hyclate). The other components are: starch, sodium lauryl sulfate, lactose, alginic acid, and magnesium stearate.
7.3 Treatment Dosage, administration, and compliance Please note the following information: The dosage will vary depending on the treatment plan prescribed for the patient. This may involve taking 50 mg (half a tablet) daily for three months, or 100 mg (one tablet) for 15 days each month for three months. Patients will take the medication at home without medical supervision. However, they will be able to contact the medical staff involved in the study if they have any questions or suspect any adverse events.
7.4 Device Accountability of the Medical Device Patients will bring the used blisters to V2 in order to perform drug accountability and calculate the compliance rate.
7.5 Concomitant and permitted and not permitted treatment Patients will be allowed to carry on any systemic medication except: - Multivitamins with minerals (Iron can bind to doxycycline in the gastrointestinal tract, which may prevent their absorption into the bloodstream and possibly reduce their effectiveness). - Other oral or systemic antibiotics - Probiotics Patient will not be able to assume other topical medications for blepharitis or MGD treatment during the study (ex: topical antibiotics or corticosteroids) except for topical lubricating agents
