Trial Outcomes & Findings for Studying the Effects of Sibutramine on Eating Behavior (NCT NCT01170364)

NCT ID: NCT01170364

Last Updated: 2017-08-30

Results Overview

The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2017-08-30

Participant Flow

45 potential participants were screened for eligibility between February, 2009 and July 2010 at an academic medical center in New York City, NY.

14 of 45 patients were randomized. Of those not randomized, 21 did not meet inclusion criteria.

Participant milestones

Measure	Sibutramine First, Then Placebo This is a cross over design study. Participants in this arm begin with one week of 15mg sibutramine, followed by two weeks of placebo.	Placebo First, Then Sibutramine This is a cross over design study. Participants in this arm begin with two weeks of placebo, followed by one week of 15mg of sibutramine
Overall Study STARTED	8	6
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Sibutramine First, Then Placebo This is a cross over design study. Participants in this arm begin with one week of 15mg sibutramine, followed by two weeks of placebo.	Placebo First, Then Sibutramine This is a cross over design study. Participants in this arm begin with two weeks of placebo, followed by one week of 15mg of sibutramine
Overall Study Protocol Violation	4	1

Baseline Characteristics

Studying the Effects of Sibutramine on Eating Behavior

Baseline characteristics by cohort

Measure	Sibutramine First, Then Placebo n=4 Participants Participants in this group were randomized to begin with 7 days of 15mg of sibutramine, followed by 14 days of placebo.	Placebo First, Then Sibutramine n=6 Participants Participants in this group were randomized to begin with 14 days of placebo, followed by 7 days of 15mg of sibutramine.	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 6 • n=5 Participants	39 years STANDARD_DEVIATION 11 • n=7 Participants	36 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: This is a cross over design study. All participants received sibutramine and placebo. The sibutramine arm listed here includes all participants who received sibutramine (regardless of whether they received it first or second). The placebo arm included all those who received placebo (regardless of whether they received it first or second).

The primary outcome measure is 24-hour food intake assessed by 24 hour weighed intake after one week of sibutramine administration compared to one week of placebo administration.

Outcome measures

Measure	Sibutramine n=9 Participants In this arm, participants received sibutramine 15mg for 7 days	Placebo n=9 Participants In this arm, participants received placebo (for 15mg sibumtramine) for 7 days.
24 Hour Measured Caloric Intake	1923 kcal Standard Deviation 655	2373 kcal Standard Deviation 774

Adverse Events

Sibutramine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sibutramine n=9 participants at risk Participants who received sibutramine 15mg capsule every morning for 7 days.	Placebo n=9 participants at risk Participants who received a placebo capsule (matching sibutramine 15mg) every morning for 7 days.
Nervous system disorders headache	22.2% 2/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Gastrointestinal disorders constipation	22.2% 2/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Gastrointestinal disorders nausea	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Gastrointestinal disorders increased appetite	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	22.2% 2/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Nervous system disorders difficulty sitting still	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Cardiac disorders irregular heartbeat	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Gastrointestinal disorders diarrhea	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Gastrointestinal disorders dry mouth	22.2% 2/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Gastrointestinal disorders decreased appetite	77.8% 7/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	22.2% 2/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Nervous system disorders tremor or shakiness	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
General disorders sour taste	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	0.00% 0/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Nervous system disorders trouble sleeping	22.2% 2/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.
Psychiatric disorders nervousness	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.	11.1% 1/9 • One week for each intervention. At assessment visits, participants were asked about the presence or absence of 22 common medication side effects.

Additional Information

Dr. Laurel Mayer

NYPInstitute

Phone: 646-774-8067

Email: lsm16@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place