Outcomes18

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 18 of 18

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Experienced at Least One Treatment Emergent Adverse Events (TEAEs)	Up to Day 72	SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	Up to Day 72	SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Changes in Vital Sign Parameters	Up to Day 72	SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Changes in Physical Examination Parameters	Up to Day 72	SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)	Up to Day 72	SAS included all randomized participants who had received at least 1 dose of the IP. 3 participants did not receive at least one dose of NAL ER but received placebo and 1 participant did not receive at least one dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether this was received in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in Forced Vital Capacity (FVC) at Day 21	Baseline, Day 21	Participants in SAS were analyzed.3 participants did not receive at least 1 dose of NAL ER but received placebo and 1 participant did not receive at least 1 dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).Overall number of participants analyzed'=participants who were evaluable for the OM.	litre(s)	MEAN
PRIMARY	Subjective Opiate Withdrawal (SOWS) Total Raw Score	Up to Day 72	Participants in SAS were analyzed.3 participants did not receive at least 1 dose of NAL ER but received placebo and 1 participant did not receive at least 1 dose of placebo but received NAL ER treatment. Data was summarized under actual treatment received (NAL ER or placebo) independently whether in Treatment Period 1 or 2 (participants who received both treatments are counted in both NAL ER and placebo columns).Overall number of participants analyzed'=participants who were evaluable for the OM.	score on a scale	MEAN
PRIMARY	Daytime Cough Frequency at Baseline	At Baseline	Full Analysis Set (FAS) included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period.	coughs per hour	MEAN
PRIMARY	Percent Change From Baseline in Daytime Cough Frequency at Day 22	Baseline, Day 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure.	percent change	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in Daytime Cough Frequency at Day 22	Baseline, Day 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure.	coughs per hour	MEAN
SECONDARY	Percent Change From Baseline in 24-Hour Cough Frequency at Day 22	Baseline, Day 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure.	percent change	GEOMETRIC_MEAN
SECONDARY	Percent Change From Baseline in Nighttime Cough Frequency at Day 22	Baseline, Day 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure.	percent change	GEOMETRIC_MEAN
SECONDARY	Mean Change From Baseline in the Evaluating Respiratory Symptoms (E-RS) Diary Cough Subscale at Days 9, 16, and 22	Baseline, Days 9, 16, and 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Number analyzed' indicates the number of participants with data available for analysis at the specified timepoint.	score on a scale	MEAN
SECONDARY	Mean Change From Baseline in E-RS Breathlessness Score at Days 9, 16, and 22	Baseline, Days 9, 16, and 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Number analyzed' indicates the number of participants with data available for analysis at the specified timepoint.	score on a scale	MEAN
SECONDARY	Mean Change From Baseline in the Cough Severity Numerical Rating Scale (NRS) at Days 8, 15, and 21	Baseline, Days 8, 15, and 21	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Number analyzed' indicates the number of participants with data available for analysis at the specified timepoint.	score on a scale	MEAN
SECONDARY	Mean Change From Baseline in the 14-item EXAcerbation of Chronic Pulmonary Disease Tool (EXACT) v1.1 e-Diary Tool Total Score at Days 9, 16, and 22	Baseline, Days 9, 16, and 22	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Number analyzed' indicates the number of participants with data available for analysis at the specified timepoint.	score on a scale	MEAN
SECONDARY	Mean Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 Fatigue Short Form 7a Scale Total Score at Day 21	Baseline, Day 21	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure.	score on a scale	MEAN
SECONDARY	Clinical Global Impression of Change (CGI-C) Over Time Measured at Day 21	At Day 21	FAS included all randomized participants who had received at least single dose of the study medication and provided study baseline and at least one post -baseline primary efficacy variable assessment during the treatment Period. 'Overall number of participants analyzed' included those participants who were evaluable for this outcome measure.	score on a scale	MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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