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NCT ID: NCT05462756 Completed - Type 2 Diabetes Clinical Trials

A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections

QWINT-4
Start date: August 11, 2022
Phase: Phase 3
Study type: Interventional

The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.

NCT ID: NCT05425732 Completed - Clinical trials for Pneumococcal Infection

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Start date: July 13, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

NCT ID: NCT05413902 Completed - Pain Management Clinical Trials

Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery

Start date: April 5, 2021
Phase: Phase 4
Study type: Interventional

This study consisted of a randomized controlled trial designed to evaluate a Multimodal Analgesia (MMA) Protocol on patients undergoing Posterior Spinal Fusion. The purpose is to describe the narcotic requirements and usage during the perioperative period of posterior spinal fusion and instrumentation surgery with the implementation of multimodal anesthesia protocol. The study will consist of two parallel arms, with Group 1 receiving our MMA protocol and Group 2 receiving a traditional opioid-based regime. The primary outcome of this study will be the reported Visual Analog Scale (VAS) for pain at 12, 24, and 48 hours after surgery. We considered that our findings could contribute to the fight against the opioid crisis proving alternatives to opioids as feasible alternatives for pain management even in significant surgery, as is posterior spinal fusion with instrumentation.

NCT ID: NCT05412004 Completed - Obesity Clinical Trials

Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

SURMOUNT-OSA
Start date: June 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.

NCT ID: NCT05409235 Completed - Clinical trials for Diabetic Retinopathy

Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

Start date: July 29, 2022
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.

NCT ID: NCT05393414 Completed - Pain Clinical Trials

Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement

Start date: November 25, 2019
Phase: N/A
Study type: Interventional

An alternate perioperative pain control protocol composed of intravenous ketorolac and oral acetaminophen for patients who underwent total knee replacement was designed with the aim to determine its efficacy when compared to pain control with intravenous morphine and oral oxycodone combined with acetaminophen. In addition, the study will evaluate the differences and similarities in the Hispanic population that could predict protocol efficacy.

NCT ID: NCT05259917 Completed - Clinical trials for Hereditary Angioedema

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Start date: February 23, 2022
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult Patients

NCT ID: NCT05248893 Completed - Glabellar Lines Clinical Trials

A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Start date: February 25, 2022
Phase: Phase 3
Study type: Interventional

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines. AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States. This is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment during the study. Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

NCT ID: NCT05194124 Completed - Clinical trials for Bardet-Biedl Syndrome

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Patients With Specific Gene Defects in the MC4R Pathway

Start date: December 21, 2021
Phase: Phase 3
Study type: Interventional

A trial to compare the weekly and daily formulations of setmelanotide in patients with genetic defects in the melanocortin-4 receptor pathway.

NCT ID: NCT05177094 Completed - Clinical trials for Diabetic Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Diabetic Peripheral Neuropathic Pain

Start date: January 26, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and efficacy of study drug LY3526318 for the treatment of diabetic peripheral neuropathic pain (DPNP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.