A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough (CANAL)
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ClinicalTrials.gov Identifier: NCT04030026 |
Recruitment Status :
Completed
First Posted : July 23, 2019
Last Update Posted : May 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Nalbuphine Idiopathic Pulmonary Fibrosis Cough | Drug: NAL ER Drug: Placebo | Phase 2 |
This is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study in IPF subjects with NAL ER tablets for the treatment of cough. The study consists of 2 treatment periods of 3 weeks, each followed by a washout period of 2 weeks.
Treatment Period 1: During Treatment Period 1, eligible subjects will be randomized (1:1) to one of the following treatment arms:
- Arm 1: Active NAL ER followed by crossover Placebo in Treatment Period 2
- Arm 2: Placebo followed by crossover NAL ER in Treatment Period 2
Following 3 weeks of dosing in Treatment Period 1, subjects will complete a 2-week washout period before entering Treatment Period 2. Subjects assigned to Arm 1 will receive placebo and subjects assigned to Arm 2 will receive NAL ER during Treatment Period 2. A final 2-week washout period will occur at the completion of Treatment Period 2.
NAL ER Dosing Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg twice a day (BID) over a 5-day period and then maintained at 54 mg twice a day (BID) for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg twice a day (BID) over 1 week and then to 162 mg twice a day (BID) over 6 days.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Randomized, double-blinded, placebo-controlled, 2-Treatment, 2-Period Crossover Study |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Matching Placebo |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | August 8, 2019 |
Actual Primary Completion Date : | May 27, 2022 |
Actual Study Completion Date : | May 27, 2022 |
Arm | Intervention/treatment |
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Experimental: NAL ER then placebo
Participants will receive NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID over a 3 week period, followed by a 2 week washout. They will then receive Placebo tablet (matching NAL ER BID) for 3 weeks.
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Drug: NAL ER
Participants will receive NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID over a 3 week period.
Other Name: Nalbuphine Drug: Placebo Participants will receive Placebo tablet (matching NAL ER BID) over a 3 week period.
Other Name: Nalbuphine |
Experimental: Placebo then NAL ER
Participants will receive Placebo tablet (matching NAL ER BID) for 3 weeks, followed by a 2 week washout. They will then receive NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID over a 3 week period .
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Drug: NAL ER
Participants will receive NAL ER 27 mg QD, 27 mg BID, 54 mg BID, 108 mg BID, 162 mg BID over a 3 week period.
Other Name: Nalbuphine Drug: Placebo Participants will receive Placebo tablet (matching NAL ER BID) over a 3 week period.
Other Name: Nalbuphine |
- Comparison of percentage of responders by Treatment [ Time Frame: Up to 3 weeks ]To evaluate the effect of Nalbuphine ER tablets on the mean daytime cough frequency (coughs per hour) at day 22 (dose 162 mg twice daily [BID]) as compared to placebo. Daytime is defined as the period between the time the subject reported being awake and the time the subject went to bed. Assessment is done using objective digital cough monitoring.
- Change from baseline daytime cough frequency effect of escalating doses of Nalbuphine ER [ Time Frame: Up to 3 weeks ]To evaluate the effect of escalating doses of Nalbuphine ER on the mean relative change from baseline in daytime cough frequency (coughs per hour) at day 9 (dose: 54 mg BID), day 16 (dose: 108 mg BID) and day 22 (dose: 162 mg BID).
- Comparison of percentage of responders on the Evaluating Respiratory Symptoms (E-RS™) diary cough scale [ Time Frame: Up to 3 weeks ]The E-RS will be used to look at the percentage of responders with response defined as at least one category improvement from baseline.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Individuals diagnosed with Idiopathic Pulmonary Fibrosis
- Chronic cough > 8 weeks.
- Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening
Exclusion Criteria:
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The following conditions are excluded:
- Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.
- Interstitial lung disease (ILD) known to be caused by connective tissue disease.
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Interstitial lung disease (ILD) known to be caused by drug related toxicity.
2. Currently on continuous oxygen therapy.
3. History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030026
United Kingdom | |
11 | |
Antrim, Northern Ireland, United Kingdom, BT9 7AB | |
16 | |
Birmingham, United Kingdom, DD1 9SY | |
09 | |
Cambridge, United Kingdom, CB23 3RE | |
08 | |
Cottingham, United Kingdom, HU16 5JQ | |
17 | |
Dundee, United Kingdom, DD1 9SY | |
13 | |
Edinburgh, United Kingdom | |
04 | |
London, United Kingdom, NW1 2BU | |
01 | |
London, United Kingdom, SW3 6NP | |
02 | |
Manchester, United Kingdom, M23 9LT | |
10 | |
Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
15 | |
North Shields, United Kingdom, NE29 8NH | |
07 | |
Norwich, United Kingdom, NR4 7UY | |
06 | |
Nottingham, United Kingdom, NG5 1PB | |
14 | |
Oxford, United Kingdom | |
03 | |
Southampton, United Kingdom, SO16 6YD |
Study Director: | Thomas Sciascia | Trevi Therapeutics, Inc |
Responsible Party: | Trevi Therapeutics |
ClinicalTrials.gov Identifier: | NCT04030026 |
Other Study ID Numbers: |
TR12 2018-004744-31 ( EudraCT Number ) |
First Posted: | July 23, 2019 Key Record Dates |
Last Update Posted: | May 25, 2023 |
Last Verified: | May 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Nalbuphine Cough Idiopathic Pulmonary Fibrosis Pharmacokinetics |
Pulmonary Fibrosis Cough Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Respiration Disorders |
Signs and Symptoms, Respiratory Nalbuphine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |