Effects of Nicotine 1.5mg lozenge on smoking urges in moderate smokers

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pierre Fabre Medicament

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

3 Apr 2024 → 23 May 2024

Decision date (initial)

2024-02-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To assess (prospectively) from 30 minutes up to 3 min in a reverse chronological manner the efficacy of a single dose of Nicotine 1.5mg lozenge as compared to placebo on the reduction of craving in moderate smokers in a non-smoking situation.

Secondary objectives 7

1. To assess the efficacy of a single dose of Nicotine 1.5mg lozenge as compared to placebo on the reduction of craving in moderate smokers in a non-smoking situation at 45, 60 and 90 minutes.
2. To assess the efficacy of a single dose of Nicotine 1.5mg lozenge as compared to placebo on the reduction of craving in moderate smokers in a non-smoking situation during 45, 60 and 90 minutes.
3. To assess the efficacy of a single dose of Nicotine 1.5mg lozenge as compared to placebo on the reduction of craving in moderate smokers in a non-smoking situation during 30 minutes.
4. To (prospectively) assess the efficacy over one day on overall craving of Nicotine 1.5mg lozenges as compared to placebo.
5. To evaluate the efficacy over one day of Nicotine 1.5mg lozenges as compared to placebo on affective withdrawal symptoms (anxiety, anger, irritability, difficulty concentrating, restlessness, and depressed mood).
6. To evaluate global subject’s satisfaction.
7. To assess the safety of Nicotine 1.5mg lozenges.

Conditions and MedDRA coding

Cessation of smoking

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations;
2. Male or female;
3. Aged of at least 18 years old;
4. With a BMI ranging between 18.5 and 29.5 kg/m2;
5. Moderate smoker (11-20 cigarettes/day) with a Fagerström score of 5 to 6;
6. Subjects with first item of the Fagerström score = 2 (time to first cigarette between 5 and 30 minutes after awakening);
7. Motivation for smoking cessation >7 on Richmond test at Screening and Day 0;
8. Negative serum β-HCG test (female subject of childbearing potential only) performed at Screening and Negative urine β-HCG test performed at Day 0 if the Screening serum β-HCG test has been done more than 72 hours prior to Day 0;
9. For women of childbearing potential: use of an efficient contraceptive method (oral, intravaginal and transdermal combined hormonal contraception, IUD, implant, tubal surgery or barrier method);
10. Negative antigenic test to SARs-CoV-2 or variants performed at Screening and Day 0.

Exclusion criteria 26

1. Subject with history of phenylketonuria, due to presence of aspartam;
2. Hypersensitivity to peanut or soybean, due to presence of soya oil;
3. Fructose intolerance due to presence of isomalt;
4. Hypersensitivity to nicotine or a component of the vehicle;
5. Subject with cardiac arrythmia, severe hypertension, unstable coronary disease;
6. Subject with cancer;
7. Subject with evolutive gastric or duodenal ulcer;
8. Subject with hyperthyroidism, diabetes or pheochromocytoma;
9. Subject with severe hepatic and/or renal insufficiency;
10. Subject with history of angor pectoris, myocardial infarction or stroke in the 3 months before the trial;
11. Subject with history of epilepsy;
12. Subject with asthma or COPD;
13. Subject with Parkinson disease;
14. Subject presenting with hyposalivation (including dry mouth) or hypersialorrhoea;
15. Subject with oral irritation or any disorders of the oral mucosa (aphtha, ulceration, lichen planus, stomatitis, glossitis, pharyngitis);
16. Any other relevant medical history of major medical, psychiatric illness or surgery which in the judgement of the investigator put them at risk or will be likely to modify their handling in the study treatment;
17. Use any forms of NRT in the 3 months preceding the trial;
18. Use of e-cigarette or snuse (nicotine pouch) in the 3 months preceding the trial;
19. Use of any other treatment for smoking cessation in the past 3 months preceding the trial;
20. Regular use of sedatives, hypnotics, tranquilizers, antidepressant treatments or any other addictive agents (for alcohol, WHO rules to be applied. Alcohol abuse is defined as use of > 14 units per week [one unit of alcohol is equal to 240 mL beer (5 %) or 100 mL wine (12 %) or spirits (42.5 g of 40 % volume spirit)]);
21. Pregnant or breastfeeding women;
22. Subject with an addiction (exept nicotine) or under medication used for addiction;
23. Presence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule according to Investigator’s judgement; those conditions should be assessed with the subject before randomization in the trial;
24. Subject is a family member of the investigator or any associate, colleague and employee assisting in the study conduct (secretary, nurse, technician) or is otherwise in a position likely to represent a conflict of interest, the subject is only eligible if the informed consent has been sought by an appropriately qualified individual who is completely independent of this relationship;
25. Participation in a clinical study with administration of an investigational product within 4 weeks or five times the half-life of the investigational product, whichever is longer, before the first dose of study treatment;
26. Subjects who have forfeited their freedom by administrative or legal award or is under guardianship.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Questionnaire of Smoking Urges (QSU)-brief Total score change from baseline at 30 minutes and any earlier times using.

Secondary endpoints 7

1. QSU-brief Total score improvement from Baseline.
2. QSU-brief Total score change from baseline at 45, 60 and 90 minutes.
3. Area under curve of QSU-brief Total score improvement from baseline over 30 minutes.
4. • VAS Global evaluation of the craving during the day. • Number of lozenges.
5. Change from baseline Minnesota Nicotine Withdrawal Scale (MNWS) score at the end of Day 1.
6. 5 points Lickert scale.
7. Incidence, severity, causality and outcomes of treatment-emergent adverse events (TEAEs), treatment emergent serious adverse events (TESAEs). Clinically significant abnormalities in physical examinations and vitals signs measurements.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pierre Fabre Medicament

Sponsor organisation

Pierre Fabre Medicament

Address

Les Cauquillous

City

Lavaur

Postcode

81500

Country

France

Scientific contact point

Organisation

Pierre Fabre Medicament

Contact name

Regulatory Affairs Officer

Public contact point

Organisation

Pierre Fabre Medicament

Contact name

Regulatory Affairs Officer

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications