HalfLytely with Bisacodyl Tablets Bowel Prep Kit og HalfLytely - Reformulation i Koloskopi - Kliniske forsøgsregister

Studieoversigt

Status

Afsluttet

Betingelser

Koloskopi

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

450

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- California
  - Anaheim, California, Forenede Stater, 92801
- Florida
  - Jupiter, Florida, Forenede Stater, 33458
  - Miami, Florida, Forenede Stater, 33173
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
- Maryland
  - Laurel, Maryland, Forenede Stater, 20707
- New York
  - Great Neck, New York, Forenede Stater, 11023
- North Carolina
  - Raleigh, North Carolina, Forenede Stater, 27612
- Tennessee
  - Germantown, Tennessee, Forenede Stater, 38138
- Washington
  - Bellevue, Washington, Forenede Stater, 98004
  - Spokane, Washington, Forenede Stater, 99207

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

At least 18 years of age
Otherwise in good health, as determined by physical exam and medical history
If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
Negative urine pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
Subjects with impaired consciousness that predisposes them to pulmonary aspiration
Subjects who are undergoing colonoscopy for foreign body removal and decompression
Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
Subjects who are taking drugs that may affect electrolyte levels
Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
Subjects who are pregnant or lactating, or intending to become pregnant during the study
Subjects of childbearing potential who refuse a pregnancy test
Subjects who are allergic to any preparation components
Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Enkelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Effektivitet - tilberedningskvalitet ved hjælp af en 4-punkts skala

Sekundære resultatmål

Resultatmål
Safety - patient-reported preparation related side-effects

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Braintree Laboratories

Efterforskere

Ledende efterforsker: Michael Goldstein, M.D., Long Island GI Research Group

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2006

Studieafslutning

1. august 2006

Datoer for studieregistrering

Først indsendt

13. januar 2006

Først indsendt, der opfyldte QC-kriterier