NCT04030026Phase 2Completed

A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-05-27Actual

Enrollment · participants42Actual

Source updated2025-05-29Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Idiopathic Pulmonary Fibrosis

Treatments or interventions studied

NAL ERDrugAlso known as Nalbuphine
PlaceboDrugAlso known as Placebo matched to NAL ER

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs); description: 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.; timeFrame: Up to Day 72; measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters; description: The clinical laboratory parameters included the urinalysis, hematology, serum chemistry, coagulation and liver function parameters. Clinical significance was determined by the investigator.; timeFrame: Up to Day 72; measure: Number of Participants With Clinically Significant Changes in Vital Sign Parameters; description: Vital signs measurements included blood pressure, heart rate, and respiration rate, body temperature, pulse oximetry, and weight. Clinical significance was determined by the investigator.; timeFrame: Up to Day 72; measure: Number of Participants With Clinically Significant Changes in Physical Examination Parameters; description: 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.; timeFrame: Up to Day 72; measure: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG); description: 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.; timeFrame: Up to Day 72; measure: Change From Baseline in Forced Vital Capacity (FVC) at Day 21; description: Spirometry was used to assess FVC. It was used to assess pulmonary breathing mechanics.; timeFrame: Baseline, Day 21; measure: Subjective Opiate Withdrawal (SOWS) Total Raw Score; description: 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.; timeFrame: Up to Day 72; measure: Daytime Cough Frequency at Baseline; description: 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.; timeFrame: At Baseline; measure: Percent Change From Baseline in Daytime Cough Frequency at Day 22; description: 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.; timeFrame: Baseline, Day 22

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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