Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01296698 · ClinicalTrials.gov registry record · Phase 3
Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking
A Phase 3 study, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
- Terminated
- Registry status
- Phase 3
- Development phase
- 257
- Enrollment target
NCT01296698: Clinical Trial Phase 3 study, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
NCT01296698 is a Phase 3 study that was terminated before completion, run by McNeil Consumer Healthcare Division of McNEIL-PPC. The registered enrollment target is 257 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01296698, a Phase 3 study, was terminated before completion, sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 257 participants
- Enrollment target
Study Summary
This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home. Approximately 1500 subjects will be enrolled into the study. The study will require participants to use the treatment for 12 weeks and there will be a 14-week follow-up period. The study will be conducted in approximately 20 pharmacies across the United States. At the first visit to the pharmacy, participants will be asked some questions to see if they are eligible to participate. Participants will be asked to sign a consent form if they agree to participate. Participants will answer some more questions, and blow into a machine to measure their carbon monoxide (CO) levels to make sure they qualify for the trial. Participants will be asked to go to a nearby dentist who will look at their mouths. Participants will go back to the pharmacy and if they qualify, they will be given a supply of their assigned treatment. They will have an equal chance of receiving a treatment that has a drug in it or one that has no drug in it. They will be given a diary to keep track of how much of the treatment they use. Subjects will go to the pharmacy four more times to hand in their diaries and blow into a machine that will measure their CO levels. At the last visit, subjects will have their mouths examined by a dentist again to have their mouth checked. Subjects will receive four telephone calls during the study where they will be asked some questions. After the 12 week treatment period, subjects will receive two to three more telephone calls, where they will be asked to answer some questions. Participants may be asked to come back to the pharmacy two more times to blow into the carbon monoxide machine again.
Interventions
- DRUG Placebo
- DRUG Nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 257 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01296698
The ClinicalTrials.gov registry entry for NCT01296698 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 257 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McNeil Consumer Healthcare Division of McNEIL-PPC, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01296698 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01296698 about?
NCT01296698 is a clinical study titled "Study to Determine if a New Nicotine Replacement Therapy Can Safely Help Smokers to Quit Smoking". This study is to see if a new nicotine replacement therapy safely helps people to quit smoking if it is used the way it would be if it were sold at the pharmacy and used at home. Approximately 1500 subjects will be enrolled into the study. The study will require participants to use the treatment for...
What is the current status of trial NCT01296698?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 257 participants. The study started on 2011-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01296698?
The interventions under investigation include: Placebo (DRUG), Nicotine (DRUG).
Who is sponsoring clinical trial NCT01296698?
This trial is sponsored by McNeil Consumer Healthcare Division of McNEIL-PPC, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.