A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
This study has been completed.
Sponsor:
Rock Creek Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Rock Creek Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01262170
First received: December 15, 2010
Last updated: August 17, 2012
Last verified: August 2012
| Tracking Information | |||||
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| First Received Date ICMJE | December 15, 2010 | ||||
| Last Updated Date | August 17, 2012 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Effect on subject's craving to smoke [ Time Frame: 4 hours ] [ Designated as safety issue: No ] craving is assessed by changes in questionnaire answers over time |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01262170 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Collection of information on adverse events related to study products [ Time Frame: 5 hours ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Active-Controlled, Crossover, Pilot Study to Evaluate the Safety and Efficacy of CigRx™ Lozenge, a Non-Nicotine Non-Tobacco Dietary Supplement, in Daily Smokers in Temporarily Reducing the Desire to Smoke | ||||
| Brief Summary | A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke |
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| Detailed Description | Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 109 | ||||
| Completion Date | April 2010 | ||||
| Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 23 Years to 72 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01262170 | ||||
| Other Study ID Numbers ICMJE | RCP-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rock Creek Pharmaceuticals, Inc. | ||||
| Study Sponsor ICMJE | Rock Creek Pharmaceuticals, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rock Creek Pharmaceuticals, Inc. | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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