A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

Sedation Clinical Trial

Official title:

A Double-blind, Randomized, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127438
• Other study ID #: E2083-A001-406
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2010
• Last updated: February 6, 2013
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.

Description:

This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age >/= 65 years, and/or weight < 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight >/= 55 kg and weight < 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Subjects who meet all of the following criteria will be included in the study:

1. Male and female adult candidates for diagnostic or therapeutic colonoscopy with at least one of the following characteristics:

• Subgroup 1: Weight < 60 kg and age >/= 18 to < 65 years and ASA I or II;

• Subgroup 2: Weight < 60 kg and age >/= 65 years and/or ASA 3 or 4; or

• Subgroup 3: Weight >/=60 kg and age >/= 65 years and/or ASA 3 or 4.

2. Females of childbearing potential must have a negative beta human chorionic gonadotropin (?hCG) urine pregnancy test at Visit 1 (Screening) and prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device [IUD], or have a vasectomised partner) having starting for at least 1 menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential;

3. Are willing and able to comply with all aspects of the protocol; and

4. Provide written informed consent.

Subjects who meet any of the following criteria will be excluded from participation in the study:

1. Females who are pregnant (positive BhCG urine pregnancy test) or breastfeeding;

2. Subjects who do not meet nil per os (NPO) requirement of no solid foods within 8 hours and clear fluids up to 3 hours before the procedure (assessed only at Baseline);

3. Evidence of clinically significant disease or a history of a concomitant medical condition (eg, cardiac, respiratory, gastrointestinal, renal disease) that, in the opinion of the Investigator, could affect the subject's safety or ability to safely complete the study;

4. Subjects with hypersensitivity to LUSEDRA or any other components of LUSEDRA, including its active metabolite, propofol;

5. History of drug or alcohol dependency or abuse within approximately the last 2 years; or

6. The Investigator believes to be medically unfit to receive the study drug or unsuitable for any other reason.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• fospropofol disodium Subgroup 1 Lower Dose
Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II)
• fospropofol disodium Subgroup 1 Approved Dose
(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II)
• fospropofol disodium Subgroup 2 Lower Dose
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight < 60 kg and Age >/=65 years and ASA 3 or 4
• fospropofol disodium Subgroup 2 Approved Dose
(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4
• fospropofol disodium Subgroup 3 Lower Dose
(Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4
• fospropofol disodium Subgroup 3 Approved Dose
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4

Locations

Country	Name	City	State
United States	Southern California Permanente Medical Group	Baldwin Park	California
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Utah Digestive Health Institute	Clinton	Utah
United States	Ohio State University Medical Center Department of Anesthesiology	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	Gastroenterology Associates of Northern Virginia	Fairfax	Virginia
United States	Northern Utah Gastroenterology	Logan	Utah
United States	Center for Advanced Gastroenterology	Maitland	Florida
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	University of Miami School of Medicine	Miami	Florida
United States	Research Associates of New York, LLP	New York	New York
United States	Advance Clinical Research	Odgen	Utah
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Hope Research Institute	Phoenix	Arizona
United States	Digestive Health Associates	Plano	Texas
United States	Utah Clinical Trials, LLC	Salt Lake City	Utah
United States	Desta Digestive Disease Medical Center	San Diego	California
United States	Miami Research Associates	South Miami	Florida
United States	Clinical Trial Network	Spring	Texas
United States	Sheridan Clinical Research	Sunrise	Florida
United States	Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital	Tyrone	Pennsylvania
United States	Ilumina Clinical Associates	Uniontown	Pennsylvania
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Sedation Success	Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.	Day 1	No
Secondary	Number of Participants With Treatment Success	Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.	Day 1	No
Secondary	Number of Participants With Modified Sedation Success	Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.	Day 1	No