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. 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. All subjects will receive the study treatments as described in Section 3. The time of the initial study drug administration will be called “0” hours. The study drug will be administered with approximately 240 mL of water. Up to an additional 240 mL of water will be allowed, if necessary, to aid in swallowing of the study drugs. Subjects will not engage in strenuous activity at any time during the treatment period. When morning blood draws are required, study drug will be administered after blood sample collection. Study drug may be taken with or without food. The timing of TID dosing is provided in Section 3.1.2 and the timing of BID dosing is provided in Section 3.1.3. Doses of AT-752 and matching placebo should be separated by 8 hours (± 2 hours) for TID dosing and by 12 hours (±2 hours) for BID dosing. After Day 1, if a dose is delayed, it should be taken as soon as possible, but must be taken at least 6 hours before the next scheduled dose. Otherwise, the dose must be skipped and the next dose taken as scheduled. Study drug dose modifications are not permitted in the study. Dosing will be stopped at the end of the 15-dose (TID) or 10-dose (BID) treatment period. At the end of treatment period, tablets corresponding to any missed doses should be returned to the site. Subjects must take the dose that was assigned at randomization, unless they discontinue for one of the reasons noted in Section 4.3.1.
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:
1. Patients should receive eteplirsen once every 7 days starting on Study Day 1. A window of ±3 days from the scheduled dose is acceptable after the first infusion.
2. Patients may not receive 2 separate doses of eteplirsen within the same 60-hour period.
3. The medical monitor should be contacted in the event of ≥2 consecutive missed doses.
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.
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. 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:
Sequence 1: DD T2 → Oasys 1-Day Sequence 2: Oasys 1-Day → DD T2 Sequence 3: DD T2 → MyDay Sequence 4: MyDay → DD T2 Sequence 5: DD T2 → Moist Sequence 6: Moist → DD T2 Alcon - Business Use Only Protocol - Clinical Document: TDOC-0054506 Status: Effective
TREATMENTS ADMINISTERED. This is a crossover study design. Subjects will be randomized to 1 of the 2 lens sequences, as described below:
Sequence 1: DD T2 → Clariti 1 Day Sequence 2: Clariti 1 Day → DD T2
4.1 Identity of Study Treatments
4.2 Accountability Procedures Upon receipt of the study lenses, the Investigator or delegate will conduct an inventory. Designated study staff will provide the study lenses to the subjects in accordance with their randomization schedule. Throughout the study, the Investigator or delegate must maintain records of study treatment dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. It is the Investigator’s responsibility to ensure that: • All study products are accounted for and not used in any unauthorized manner • All used foils and unused supplies are returned by each subject • All unused products are available for return to the Study Sponsor, as directed • Any study lenses associated with a device deficiency or with any product-related adverse event [ie, ADE or SADE] are returned to the Study Sponsor for investigation. Refer to Section 7.3 of this protocol for additional information on the reporting of device deficiencies and AEs and the return of study products associated with these events.
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).
Figure 1. Description of injection boundary. The amount of each study products needed varies between subjects and within subjects bilaterally, given the natural asymmetry of the face. However, subjects will be treated to optimal correction of the midface as agreed by the Investigator and subjects. The product volume injected during each treatment session for each subject will be recorded in the CRFs.
TREATMENTS ADMINISTERED. All doses of study drug will be administered by mouth with 240 mL of room temperature water. During the study, subjects may consume water on an ad libitum basis. Hepatically impaired subjects will receive a diet standardized for hepatic impairment and healthy control subjects will receive a similar diet. Subjects should receive these meals at the same time during each part of the study.
