Trial · NCT02993822

A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

NCT02993822, Phase 2, Completed, Nerre Therapeutics Ltd.; results first posted 2022-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough. Trials, record NCT02993822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993822

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough
NCT number: NCT02993822
Status: Completed
Phases: Phase 2
Enrollment: 315 participants, actual
Lead sponsor: Nerre Therapeutics Ltd.
Conditions: Chronic Refractory Cough
Interventions: Orvepitant Maleate, Placebo
First posted: 2016-12-15
Last updated: 2022-04-26
Results first posted: 2022-04-26

Source ClinicalTrials.gov

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 in Awake Objective Cough Frequency	Baseline to Week 12	Objective cough frequency measured by ambulatory cough monitoring device
Secondary	Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	Baseline to Week 2	Objective cough frequency measured by ambulatory cough monitoring device
Secondary	Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline	Week 4	Objective cough frequency measured by ambulatory cough monitoring device
Secondary	Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline	Baseline to Week 2	The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Secondary	Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline	Baseline to Week 4	The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Secondary	Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline	Baseline to Week 8	The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Secondary	Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline	Baseline to Week 12	The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Secondary	Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time	Baseline to Week 2	The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Secondary	Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time	Baseline to Week 4	The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
Secondary	Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time	Baseline to Week 8	The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.

1 to 10 of 27Source ClinicalTrials.gov

See all 27 registered outcomes

Outcomes27

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 12 in Awake Objective Cough Frequency	Baseline to Week 12	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	coughs per hour (log transformed)	MEAN
SECONDARY	Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	Baseline to Week 2	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	coughs per hour (log transformed)	MEAN
SECONDARY	Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline	Week 4	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	coughs per hour (log transformed)	MEAN
SECONDARY	Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline	Baseline to Week 2	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Total score	MEAN
SECONDARY	Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline	Baseline to Week 4	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Total score	MEAN
SECONDARY	Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline	Baseline to Week 8	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Total score	MEAN
SECONDARY	Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline	Baseline to Week 12	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Total score	MEAN
SECONDARY	Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time	Baseline to Week 2	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Score	MEAN
SECONDARY	Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time	Baseline to Week 4	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Score	MEAN
SECONDARY	Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time	Baseline to Week 8	The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).	Score	MEAN

1 to 10 of 27Source ClinicalTrials.gov

See all 27 outcomes

Results by group172

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 12 in Awake Objective Cough Frequency	Orvepitant 10mg	-0.185	Standard Deviation 0.3258	coughs per hour (log transformed)
Change From Baseline to Week 12 in Awake Objective Cough Frequency	Orvepitant 20mg	-0.192	Standard Deviation 0.3405	coughs per hour (log transformed)
Change From Baseline to Week 12 in Awake Objective Cough Frequency	Orvepitant 30mg	-0.271	Standard Deviation 0.4055	coughs per hour (log transformed)
Change From Baseline to Week 12 in Awake Objective Cough Frequency	Placebo	-0.243	Standard Deviation 0.3225	coughs per hour (log transformed)
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	Orvepitant 10mg	-0.180	Standard Deviation 0.2791	coughs per hour (log transformed)
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	Orvepitant 20mg	-0.181	Standard Deviation 0.3142	coughs per hour (log transformed)
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	Orvepitant 30mg	-0.215	Standard Deviation 0.2515	coughs per hour (log transformed)
Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline	Placebo	-0.139	Standard Deviation 0.2892	coughs per hour (log transformed)
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline	Orvepitant 10mg	-0.188	Standard Deviation 0.3292	coughs per hour (log transformed)
Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline	Orvepitant 20mg	-0.231	Standard Deviation 0.3665	coughs per hour (log transformed)

1 to 10 of 172Source ClinicalTrials.gov

See all 172 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Orvepitant 10mg	79
Overall Study	STARTED	Orvepitant 20mg	78
Overall Study	STARTED	Orvepitant 30mg	79
Overall Study	STARTED	Placebo	79
Overall Study	COMPLETED	Orvepitant 10mg	69
Overall Study	COMPLETED	Orvepitant 20mg	74
Overall Study	COMPLETED	Orvepitant 30mg	69
Overall Study	COMPLETED	Placebo	75
Overall Study	NOT COMPLETED	Orvepitant 10mg	10
Overall Study	NOT COMPLETED	Orvepitant 20mg	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Orvepitant 10mg	5	79	6
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Orvepitant 20mg	1	78	2
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Orvepitant 30mg	4	79	5
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Placebo	3	79	3
other	Headache	Nervous system disorders	Orvepitant 10mg	7	79	7
other	Headache	Nervous system disorders	Orvepitant 20mg	10	78	19
other	Headache	Nervous system disorders	Orvepitant 30mg	7	79	9
other	Headache	Nervous system disorders	Placebo	4	79	6
other	Dizziness	Nervous system disorders	Orvepitant 10mg	5	79	5
other	Dizziness	Nervous system disorders	Orvepitant 20mg	4	78	4

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Orvepitant 10mg	0	79
Total, all-cause mortality	Orvepitant 20mg	0	78
Total, all-cause mortality	Orvepitant 30mg	0	79
Total, all-cause mortality	Placebo	0	79
Total, other adverse events	Orvepitant 10mg	63	79
Total, other adverse events	Orvepitant 20mg	48	78
Total, other adverse events	Orvepitant 30mg	53	79
Total, other adverse events	Placebo	40	79
Total, serious adverse events	Orvepitant 10mg	1	79
Total, serious adverse events	Orvepitant 20mg	1	78

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02993822

GET https://conductscience.org/api/trials/v1/NCT02993822/registered?page=2

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