A Phase 2, Double-blind, Randomized, Placebo-controlled, Two-Treatment, Two-Period Crossover Efficacy and Safety Study in Idiopathic Pulmonary Fibrosis (IPF) With Nalbuphine ER Tablets for the Treatment of Cough

Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)

时间窗: Up to Day 72

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

时间窗: Up to Day 72

The clinical laboratory parameters included the urinalysis, hematology, serum chemistry, coagulation and liver function parameters. Clinical significance was determined by the investigator.

Number of Participants With Clinically Significant Changes in Vital Sign Parameters

时间窗: Up to Day 72

Vital signs measurements included blood pressure, heart rate, and respiration rate, body temperature, pulse oximetry, and weight. Clinical significance was determined by the investigator.

Number of Participants With Clinically Significant Changes in Physical Examination Parameters

时间窗: Up to Day 72

Physical examination included examination of the following body systems: general appearance, eyes, ears, nose, throat, head and neck, chest and lungs, cardiovascular, abdomen, musculoskeletal, lymphatic, dermatological, neurological, and extremities. Clinical significance was determined by the investigator.

Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)

时间窗: Up to Day 72

Changes in ECG data such as heart rate, rhythm, and other clinically significant abnormalities (left ventricular hypertrophy, pathological Q-waves) were measured. Clinical significance was determined by the investigator.

Change From Baseline in Forced Vital Capacity (FVC) at Day 21

时间窗: Baseline, Day 21

Spirometry was used to assess FVC. It was used to assess pulmonary breathing mechanics.

Subjective Opiate Withdrawal (SOWS) Total Raw Score

时间窗: Up to Day 72

The SOWS is a self-administered scale for grading opioid withdrawal symptoms and was collected via the study issued e-diary. It consisted of 16 symptoms related to how the participant felt. Each symptom was scored between 0 to 4. The total score ranges between 0 to 64, higher score indicates more severe symptoms.

Daytime Cough Frequency at Baseline

时间窗: At Baseline

Daytime cough was defined as cough that occurs between the time that the participant is a wake in the 24 hours after the digital cough monitor was applied for use. Assessment was done using objective digital cough monitoring. Baseline was defined as the last available assessment prior to the first Treatment Period 1 IP intake.

Percent Change From Baseline in Daytime Cough Frequency at Day 22

时间窗: Baseline, Day 22

Daytime cough was defined as cough that occurs between the time that the participant is a wake in the 24 hours after the digital cough monitor was applied for use. Assessment was done using objective digital cough monitoring. Percent change in daytime cough frequency (coughs per hour) from baseline was assessed. Baseline was defined as the last available assessment prior to the first Treatment Period 1 IP intake.