5 results about "Placebo" patented technology

Blinding Device for Injection Devices In one aspect the present disclosure relates to a blinding device (50) for concealing an injection device (1) in clinical trials, wherein the injection device (1) comprises a movable plunger (20) and an elongated barrel (10) extending in a longitudinal direction (2, 3) and filled with a medicament (8) or with a placebo, wherein the plunger (20) is longitudinally movable relative to the barrel (10) for expelling the medicament (8) or the placebo from the barrel (10) and wherein the injection device (1) comprises a flange portion (17, 18) at or near a proximal end of the barrel (10), the blinding device (50) comprising: - an opaque housing (52) to cover the barrel (10) and the plunger (20), the opaque housing (60) comprising: - a barrel cover portion (54) to receive and to cover the barrel (10), - a plunger cover portion (56) of variable longitudinal extent to receive and to cover the plunger (20), and - a housing flange portion (55) protruding outwardly from the barrel cover portion (54), wherein the housing flange portion (55) comprises a first flange part (61) and a second flange part (62), which are mutually connectable to form a flange assembly (66) connecting the barrel cover portion (54) with the plunger cover portion (56). (Fig. 1)

Disclosed herein are delivery devices for delivering a volume of a drug product, placebo product, or other product including a fluid. The devices may include a barrel having a longitudinal axis, a proximal end region, and a distal end region. The proximal end region may include an opening, and the barrel may be configured to receive a drug therein. A plunger rod may be disposed at least partially inside the barrel and protruding from the opening. The plunger rod may include a rack having a plurality of teeth. The device may further include a pinion having a plurality of teeth configured to engage with the plurality of teeth of the rack, and rotation of the pinion against the rack may move at least a part of the plunger rod along the longitudinal axis of the barrel.

The present disclosure provides methods for treating or managing fibromyalgia and its associated symptoms in a subject in need hereof characterized by an early onset of one or more of: (1) a reduction in widespread pain characterized by about 0.3 or more difference in the LS mean change in the NRS Pain Score; (2) a reduction in sleep disturbance characterized by about 2.9 or more difference in the LS Mean change in PROMIS Sleep Disturbance T-score; (3) a reduction in fatigue characterized by about 2.0 or more difference in the LS Mean change in PROMIS Fatigue T-score; or (4) an improved sleep quality characterized by about 0.5 or more difference in the LS Mean change in NRS Sleep Quality Score, each as compared to placebo, comprising administering to a subject in need thereof 2.8 mg or 5.6 mg cyclobenzaprine HCl once daily in one or more dosage units by transmucosal administration. The present disclosure also provides methods for preventing or avoiding one or more of a clinically meaningful change in mean weight, a clinically meaningful change in mean systolic blood pressure or mean diastolic blood pressure, or a decline in sexual functioning in conjunction with treating or managing fibromyalgia or its associated symptoms in a subject in need thereof, the treatment or management being characterized by the transmucosal administration of cyclobenzaprine HCl in one or more dosage units (e.g., a first dosage unit or a second dosage unit). The cyclobenzaprine HCl of these methods is in the form of a mannitol eutectic (e.g., a 75% ± 2% by weight cyclobenzaprine HCl and 25% ± 2% by weight β‑mannitol eutectic) and the one or more dosage units further comprise a basifying agent.

This invention belongs to the field of probiotic application technology, specifically relating to the application of Bifidobacterium animalis TY-S01 in the preparation of products that improve lipid metabolism in obese individuals with suboptimal LDL-C. This invention applies Bifidobacterium animalis TY-S01 to obese individuals with suboptimal LDL-C, and a randomized, double-blind, placebo-controlled clinical trial has confirmed that daily supplementation with TY-S01 (3 × 10⁻⁶) for 12 consecutive weeks is effective. 10 CFU significantly reduced serum LDL-C levels in subjects (from 4.14±0.88 mmol / L to 3.84±0.89 mmol / L). P < 0.05) and TC levels (decreased from 5.63±1.12 mmol / L to 5.30±1.10 mmol / L, P < 0.05), while significantly reducing weight and BMI.

Disclosed is a method for treating a menstrual cycle disorder in a patient in need thereof, comprising: orally administering to the patient a therapeutically effective amount of pyrroloquinoline quinone (PQQ), or a pharmaceutically acceptable derivative thereof. Preliminary experimental data show that oral PQQ has a significant effect on preventing, alleviating, or treating menstrual cycle disorders compared with a placebo.