Trial record 1 of 10 for:
nalbuphine ER
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 |
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Recruitment Status :
Recruiting
First Posted : July 23, 2019
Last Update Posted : January 15, 2021
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Sponsor:
Trevi Therapeutics
Collaborator:
Parexel
Information provided by (Responsible Party):
Trevi Therapeutics
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Brief Summary:
To investigate the efficacy and safety of Nalbuphine ER (NAL ER) tablets in subjects diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and evaluate it's treatment of cough in these patients. This is a two-treatment, 2-period crossover study. Subjects will be randomized in Treatment Period 1 to either NAL ER or matching placebo and evaluate for approximately 21 days. After completion of the first phase, subjects who received NAL ER will crossover to placebo and subjects who received placebo will crossover to NAL ER to complete Treatment Period 2.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nalbuphine Idiopathic Pulmonary Fibrosis Cough | Drug: Nalbuphine ER Drug: Placebo oral tablet | 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 BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 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 |
| Estimated Primary Completion Date : | October 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Idiopathic pulmonary fibrosis
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1a: Nalbuphine ER
Active tablets containing the study drug being tested (NAL ER) twice a day for Treatment Period 1
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Drug: Nalbuphine ER
Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.
Other Name: NAL ER |
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Placebo Comparator: Arm 2a: Placebo
Placebo twice a day for Treatment Period 1
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Drug: Placebo oral tablet
Placebo Comparative will be given in Arm 1b and again in Arm 2a
Other Name: Placebo |
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Placebo Comparator: Arm 1b: Placebo
Placebo twice a day for Treatment Period 1
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Drug: Placebo oral tablet
Placebo Comparative will be given in Arm 1b and again in Arm 2a
Other Name: Placebo |
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Active Comparator: Arm 2b: Nalbuphine ER
Active tablets containing the study drug being tested (NAL ER) twice a day for Treatment Period 2
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Drug: Nalbuphine ER
Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.
Other Name: NAL ER |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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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 |
Criteria
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:
1) 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.
- 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
Information from the National Library of Medicine
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
Contacts
| Contact: Clinical Operation Lead | 001 203-304-2499 | clinicalops.admin@trevitherapeutics.com | |
| Contact: Kerry Thompson | 0044 7889 648549 | kthompson@trevitherapeutics.com |
Locations
| United Kingdom | |
| 11 | Recruiting |
| Belfast, United Kingdom, BT9 7AB | |
| 09 | Not yet recruiting |
| Cambridge, United Kingdom, CB23 3RE | |
| 08 | Recruiting |
| Cottingham, United Kingdom, HU16 5JQ | |
| 05 | Active, not recruiting |
| Liverpool, United Kingdom, L9 7AL | |
| 04 | Recruiting |
| London, United Kingdom, NW1 2BU | |
| 01 | Recruiting |
| London, United Kingdom, SW3 6NP | |
| 02 | Recruiting |
| Manchester, United Kingdom, M23 9LT | |
| 10 | Recruiting |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| 07 | Active, not recruiting |
| Norwich, United Kingdom, NR4 7UY | |
| 06 | Recruiting |
| Nottingham, United Kingdom, NG5 1PB | |
| 03 | Not yet recruiting |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Trevi Therapeutics
Parexel
Investigators
| 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: | January 15, 2021 |
| Last Verified: | January 2021 |
| 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 |
Keywords provided by Trevi Therapeutics:
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Nalbuphine Cough Idiopathic Pulmonary Fibrosis Pharmacokinetics |
Additional relevant MeSH terms:
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Nalbuphine Pulmonary Fibrosis Cough Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory |
Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |