Treatments Administered. This is a 3-arm, parallel, crossover group study design. In each arm, the test lens will be evaluated compared to 1 of 3 chosen control lenses. Subjects will be randomized to 1 of the 6 lens sequences, as described below:
Treatments Administered. Study medication [either Solosec (containing 2 grams of secnidazole) or matching placebo] will be orally administered, under direct observation, as a single dose with approximately 4 ounces of unsweetened applesauce. Upon completion of the primary phase (Visit 1 (baseline) to Visit 2 (Day 6-12)), patients will receive the opposite treatment (placebo patients will receive Solosec and vice versa). The study medication may be taken without regard to meals. Water may be taken after the administration of study medication to aid in swallowing (See the Solosec Package Insert, Appendix A for more detailed information). Administration of each dose of study drug will be witnessed by a qualified study site staff member and documented on the source document. All qualifying patients with T. vaginalis positive results at baseline will be asked to tell their sex partners (within at least 90 days) of their infection with T. vaginalis and to encourage them to seek appropriate treatment. Additionally, where allowed (based on legal and institutional restrictions) and at the discretion of the Investigator, all qualifying patients with T. vaginalis will be provided with a prescription for a medication for T. vaginalis (e.g., metronidazole 2g or tinidazole 2g) to deliver to their sex partner(s) (i.e., patient-delivered partner therapy).
Treatments Administered. Eligible patients will receive a weekly IV infusion of 30-mg/kg dose of eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks), until the product is commercially available or until patients can transition into a separate eteplirsen study. The dose of eteplirsen will be calculated based on the most recent patient weight obtained at the site prior to the current visit. Eteplirsen should be prepared for dosing by following the steps detailed in the study-specific Pharmacy Manual. Eteplirsen will be administered as an IV infusion over a period of approximately 35 to 60 minutes, or approximately 5 mL/min. It is recommended that a topical anesthetic cream (e.g., lidocaine 2.5%, prilocaine 2.5%, or LMX4 cream) be applied to the infusion site prior to each administration of eteplirsen. Additional administration and IP details are available in the study-specific Pharmacy Manual. An implanted venous access port may be inserted for eteplirsen administration at the discretion of the Investigator. If eteplirsen is administered into an existing IV line, the line should be flushed with normal saline before and after administration of eteplirsen. After eteplirsen administration and the saline flush, the port may be flushed with heparin to heplock the port prior to removal of the infusion line. No other medications may be administered concomitantly during the eteplirsen infusion. All treated patients will be observed for at least 1 hour following the end of each eteplirsen infusion. In-home study treatment administration by a visiting nurse may be available after Week 48. The following guidelines for the timing of dosing should be followed throughout the study:
Treatments Administered. This is a crossover study design. Subjects will be randomized to 1 of the 2 lens sequences, as described below:
Treatments Administered. Alendronate sodium (Fosamax®, Merck & Co., Inc., or other approved generic manufacturer) 70 mg tablets for oral administration contain 91.35 mg of alendronate monosodium salt trihydrate which is the molar equivalent of 70 mg free acid and excipients. Alendronate should be stored in a well-closed container at room temperature, 15-30ºC. The alendronate may be generic substitutable approved versions which contain different inactive ingredients, but the amount of active free alendronate must be equivalent to 70 mg. Alendronate for Europe, Hong Kong and the US will be sourced centrally; alendronate for South America will be sourced locally by the medical center and reimbursed by the Sponsor. However, alendronate may be locally sourced in all venues when centrally supplied alendronate is unavailable due to unforeseen delays. The local source will be documented in the study drug logs. Calcium (500—1000 mg) and vitamin D (400—800 IU) supplements will be sourced locally by the medical center and provided to the subjects at the expense of the Sponsor. Subjects will continue to take calcium and vitamin D as they did in Study BA058-05-003.
Treatments Administered. Alendronate sodium (Fosamax®, Merck & Co., Inc., or other approved generic manufacturer) 70 mg tablets for oral administration contain 91.35 mg of alendronate monosodium salt trihydrate which is the molar equivalent of 70 mg free acid and excipients. Alendronate should be stored in a well-closed container at room temperature, 15-30ºC. The alendronate may be generic substitutable approved versions which contain different inactive ingredients, but the amount of active free alendronate must be equivalent to 70 mg. Alendronate for Europe, Hong Kong and the US will be sourced centrally; alendronate for South America will be sourced locally by the medical center and reimbursed by the Sponsor. Calcium (500—1000 mg) and vitamin D (400—800 IU) supplements will be sourced locally by the medical center and provided to the subjects at the expense of the Sponsor. Subjects will continue to take calcium and vitamin D as they did in Study BA058-05-003.
Treatments Administered. If not already taking calcium and vitamin D supplements at the time of screening, each subject will also begin taking Vitamin D and calcium supplements at the start of the Pretreatment Period and will continue throughout the Follow-up Period. Supplements will be provided by the study site. BA058 is an analog of the first 34 amino acids of human Parathyroid hormone related peptide (hPTHrP[1-34]). BA058 Transdermal (50 µg, 100 µg and 150 µg) and Transdermal Placebo (0µg) will be supplied as individually packaged coated transdermal arrays attached to a self-adhesive backing and mounted in a supportive cylindrical collar for use with the supplied applicator. All transdermal patches are supplied as identical presentations individually packaged for once-daily self-application. BA058 Injection will be supplied as a multi-dose cartridge for use with a pen injector. Further details for BA058 Transdermal, the BA058 Transdermal Placebo and BA058 Injection are provided in Section Error! Reference source not found. Error! Reference source not found.. Endpoints and Data Analysis Demographics and baseline characteristics of the subject population will be summarized. Treatment groups will be assessed for uniformity at baseline (baseline characteristics, medical history, physical examination, xxxxx xxxxx, ECG and parathyroid hormone [PTH] level). The efficacy endpoints to be assessed are: · Change in BMD across 6 months of treatment; · Changes in levels of PINP, PICP, BSAP, osteocalcin and CTXI across 6 months of treatment. Safety analyses will include the incidence and severity of adverse events by treatment, dose and cumulative exposure and pathological changes in hematology, chemistry and urinalysis data. Serum calcium and phosphate will be measured 4 hours post-dose at study visits occurring on Day 1, Day 8, Month 1, Month 2, Month 3, Month 4 and Month 5. Changes in physical examination, xxxxx xxxxx, ECG and clinical laboratory will be descriptively summarized. Laboratory tests will be classified as low range, normal range, or high range and shift frequencies summarized between the Baseline result and the End of Treatment Visit. [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Optimal Dose Selection Following formal analysis of the efficacy and safety data of the study, the dose(s) to be carried forward into further ...
Treatments Administered. The study products contain lidocaine hydrochloride, but additional topical or local anesthesia or ice pack may be used at the discretion of the Investigator to enhance the experience of the subjects. Any additional topical or local anesthesia used will be recorded in the CRFs. The injection tools (needles or cannulas) will be determined at the discretion of the Investigator. However, for each subject, the Investigator must use the same type of injection tool to perform injection for both sides of the face. Switching device within the subject will not be allowed in order to avoid any inconsistent comparison. Either needles or cannulas will be used per subject. The brand name, gauge and length of the cannulas and incision needles used by the Investigator will be recorded in the CRFs. The study products will be injected into the midface at the supraperiosteal to subcutaneous layer in the prezygomatic space lateral to the plane of the medial canthus, along the plane of the zygomatic arch ~1cm medial to hairline (described in Figure 1 below).
