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| Tracking Information | |||||
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| First Received Date ICMJE | January 13, 2006 | ||||
| Last Updated Date | October 18, 2006 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Efficacy - preparation quality using a 4-point scale | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00278967 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety - patient-reported preparation related side-effects | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects | ||||
| Official Title ICMJE | An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects | ||||
| Brief Summary | To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects. |
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| Detailed Description | The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Colonoscopy | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 450 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications: Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00278967 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | F38-26 | ||||
| Study Sponsor ICMJE | Braintree Laboratories | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Braintree Laboratories | ||||
| Verification Date | October 2006 | ||||
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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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