Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Temporarily halted
Participants planned
650
Countries
1
Sites
15
Smokers smoking at least 10 cigarettes/day in the past year
To assess the efficacy of electronic cigarettes containing nicotine (ECwN) comparatively to an EC without nicotine (ECwoN) and to a reference, licensed smoking cessation medication: varenicline.
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- 31 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- French Ministry of Health
External identifiers
- EU CT number
- 2024-518135-10-00
- EudraCT number
- 2017-003588-37
- ClinicalTrials.gov
- NCT03630614
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of electronic cigarettes containing nicotine (ECwN) comparatively to an EC without nicotine (ECwoN) and to a reference, licensed smoking cessation medication: varenicline.
Secondary objectives 6
- The safety profile of ECwN comparatively to to electronic cigarettes without nicotine and varenicline
- To assess the point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm
- Évaluer le temps nécessaire pour recommencer à fumer après la date d’arrêt de la consommation tabagique.
- To study the change in cigarettes/day consumption
- To study the change in craving for tobacco
- To study the change in withdrawal symptoms
Conditions and MedDRA coding
Smokers smoking at least 10 cigarettes/day in the past year
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10053325 | Smoking cessation therapy | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Smokers smoking at least 10 cigarettes/day (factory made or roll-your-own) in the past year
- Aged 18 to 70 years
- Motivated to quit defined as a score > 5 on a visual rating scale ranging from 0 (not motivated at all) to 10 (extremely motivated)
Exclusion criteria 8
- any unstable disease condition within the last 3 months defined by the investigator as major change in symptoms or treatments, such as : see protocol
- any life threatening condition with life-expectancy of less than 3 months
- alcohol use disorder defined as a score ? 10 on the AUDIT-C questionnaire
- abuse of or dependence on illegal drugs in the last 6 months revealed by the medical history
- regular use of tobacco products other than cigarettes
- current or previous (last 6 months) use of electronic cigarette
- pregnant women
- breastfeeding women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Continuous smoking abstinence rate during the last 4 weeks of a treatment period of 3 months.
Secondary endpoints 6
- The assessment criterion of the safety will be the comparison of serious adverse events and non-serious adverse events
- Point prevalence abstinence: self-report of 7-day smoking abstinence at each visit associated with expired air CO ≤ 8 ppm.
- Time to relapse to smoking after the predefined target quit day
- Change in cigarettes/day consumption
- Change in craving for tobacco
- Change in withdrawal symptoms
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CHAMPIX 0.5 mg film-coated tablets
PRD6494399 · Product
- Active substance
- Varenicline
- Substance synonyms
- CP-526,555, OC-01
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 173.5 mg milligram(s)
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- N07BA03 — -
- Marketing authorisation
- EU/1/06/360/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Mise en insu des comprimés et flacons en coffret DI anonymisé
Placebo 1
Placebo CHAMPIX ® 0.5mg Comprimé pelliculé
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Ivan Berlin
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Ivan Berlin
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 650 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Pneumologie, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
CHU Caremeau Service de Neurologie
0466686998, CHU Caremeau, Service de Neurologie, Nîmes
Dispensaire Emile Roux
Santé Publique, 11 Rue Vaucanson, 63100, Clermont-Ferrand,
Centre Hospitalier Universitaire De Saint Etienne
Tabacologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Caen Normandie
Tabacologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Lille
Pneumologie, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire D'Angers
Pneumologie, 4 Rue Larrey, 49100, Angers
CHRU De Nancy
Pneumologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier Saint Joseph Saint Luc
Addictologie, 20 Quai Claude Bernard, 69007, Lyon
Centre Hospitalier Henri Laborit
Unité de Recherche Clinique, 370 Avenue Jacques Coeur, Cs 10587, Poitiers
Assistance Publique Hopitaux De Paris
Centre d’Investigation Clinique Paris Est, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Assistance Publique Hopitaux De Paris
Psychiatrie et addictologie, 12 Avenue Paul Vaillant Couturier, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Psychiatire addictologie, Avenue Du Haut Leveque, 33600, Pessac
Hopital Antoine-Beclere
Équipe de liaison et soins en addictologie : ELSA, 157 Rue De La Porte De Trivaux, 92140, Clamart
Hopital Tenon
Pneumologie, 4 Rue De La Chine, 75970, Paris Cedex 20
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-10-31 | 2024-10-31 | 2024-10-31 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-126070
- Halt date
- 2024-10-31
- Planned restart
- 2027-09-05
- Member states concerned
- France
- Publication date
- 2026-03-27
- Reason
- Medicinal Product related
- Explanation
- Inclusion in this clinical trial was suspended on 12/07/2022 due to the withdrawal of
Varenicline from the market following an impurity detected in Varenicline (CHAMPIX®)
tablets at the manufacturing line level, and a worldwide recall of Varenicline (CHAMPIX®)
batches.).
The study will resume as soon as CHAMPIX is reintroduced to the market. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocole 2024-518135-10-00 | 5 |
| Protocol (for publication) | D1_Protocole IP list | 3 |
| Protocol (for publication) | D1_Protocole pregnancy report form | 1 |
| Protocol (for publication) | D1_Protocole recruitment poster | 2 |
| Protocol (for publication) | D1_Protocole SAE report form | 1 |
| Protocol (for publication) | D1_Protocole scales | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF adult | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF adult- addendum | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_CHAMPIX_0,5 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocole synopsis | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | France | Acceptable 2024-10-31
|
2024-10-31 |