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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030026
Recruitment Status : Active, not recruiting
First Posted : July 23, 2019
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Trevi Therapeutics

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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 : December 20, 2020
Estimated Study Completion Date : June 5, 2021


Arm Intervention/treatment
Active Comparator: Arm 1a: Nalbuphine ER
Active tablets containing the study drug being tested (NAL ER) twice a day for Treatment Period 1
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

Placebo Comparator: Arm 2a: Placebo
Placebo twice a day for Treatment Period 1
Drug: Placebo oral tablet
Placebo Comparative will be given in Arm 1b and again in Arm 2a
Other Name: Placebo

Placebo Comparator: Arm 1b: Placebo
Placebo twice a day for Treatment Period 1
Drug: Placebo oral tablet
Placebo Comparative will be given in Arm 1b and again in Arm 2a
Other Name: Placebo

Active Comparator: Arm 2b: Nalbuphine ER
Active tablets containing the study drug being tested (NAL ER) twice a day for Treatment Period 2
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 :
  1. 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 :
  1. 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).

  2. 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:

  1. Individuals diagnosed with Idiopathic Pulmonary Fibrosis
  2. Chronic cough > 8 weeks.
  3. Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening

Exclusion Criteria:

1) The following conditions are excluded:

  1. Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures.
  2. Interstitial lung disease (ILD) known to be caused by connective tissue disease.
  3. 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


Locations
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United Kingdom
11
Belfast, United Kingdom, BT9 7AB
09
Cambridge, United Kingdom, CB23 3RE
08
Cottingham, United Kingdom, HU16 5JQ
05
Liverpool, United Kingdom, L9 7AL
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
07
Norwich, United Kingdom, NR4 7UY
06
Nottingham, United Kingdom, NG5 1PB
03
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Trevi Therapeutics
Parexel
Investigators
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Study Director: Thomas Sciascia Trevi Therapeutics, Inc
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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: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Trevi Therapeutics:
Nalbuphine
Cough
Idiopathic Pulmonary Fibrosis
Pharmacokinetics
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Cough
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents