Clinical Trial Search

Primary: To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main…

Primary: Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale — -3.10; -3.49; -2.80 units on a scale

Primary: Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale — 27.3; 44.4; 36.4 percentage of subjects

Primary: Drug Self-administration — 350; 255; 223; 113 Clicks on a computer mouse

Primary: Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) — 133 Participants

Primary: Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER — 3.30; 7.67; 13.9; 18.7 nanogram per milliliter (ng/mL)

Primary: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs) — 35; 26 Participants

Primary: Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs) — 34 Participants

Primary: Percentage of Participants With ≥ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14 — 24.24; 14.50 percentage of participants…

Primary: Change in Minute Ventilation 5 Minutes From Opioid Induced Nadir — 4.42; 2.03 L/min

Primary: Urine Toxicology for Opiate Use — 2; 4; 2; 0 Participants

Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 33; 47 Participants

Primary: Length of Treatment — 15; 28 days — p=<0.05

Primary: Successful Discontinuation of Buprenorphine — 6 Participants

Primary: Buprenorphine Pharmacokinetics

Primary: Retention in Treatment — 26 participants

Primary: Drug's Breakpoint — 1200; 10; 1100; 1200 number of clicks on a mouse

Primary: Effects of Naloxone on Heart Rate (HR). — 73.3; 70.6 bpm

Primary: Successful Induction Onto XR-NTX — 8 Participants

Primary: Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing. — 8; 5; 4; 6 participants

Primary: Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) — 264.6; 264.0 Units on a scale — p=0.9703

Primary: Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. — -2.32; -2.75 Scores on a scale — p=0.2658

Primary: Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3) — -3.7; -2.7 units on a scale

Primary: Overall Opioid Dose (Morphine-equivalent Dose in mg) — 19.6; 19.6; 19.6 mg

Primary: Change From Baseline to Week 12 in Average Daily Pain Intensity Scores — 0.94; 1.59 units on a scale — p=0.0012

Primary: Pain Score, Visual Analogue Pain Scores — 1.9 units on a scale

Primary: Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration…

Primary: NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration — 4; 3 score on a scale — p=0.132

Primary: Pain Measured Based on Pain Medication Used on a Scale of 0-10 — 1.3; 0.7 units on a scale

Primary: Number of Hours Until Tolerating Oral Intake — 25.9; 25.0 hours