Trial Outcomes & Findings for Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight (NCT NCT00832520)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-04-10

Participant Flow

Enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible. The recruitment period spanned 07Apr2009 through 14Jul2010. All were recruited through the UNM Cancer Center medical clinic.

Participant milestones

Participant milestones
Measure	Remeron (Mirtazapine) Mirtazapine 15 mg orally at bed time for 8 weeks
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remeron (Mirtazapine) n=13 Participants Mirtazapine 15 mg orally at bed time for 8 weeks
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Age, Continuous	59 years STANDARD_DEVIATION 10 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Region of Enrollment United States	13 participants n=99 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: There will be no publication, as this study was terminated after the original PI left employment with the institution, and because enrollment was low (13 of a target 59) which rendered planned statistical analyses impossible.

Outcome measures

Outcome data not reported

Adverse Events

Remeron (Mirtazapine)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Remeron (Mirtazapine) n=13 participants at risk Mirtazapine 15 mg orally at bed time for 8 weeks
Psychiatric disorders Agitation	7.7% 1/13 • Number of events 1 Regular investigator assessment, regular laboratory testing, and self-reporting by subjects.
General disorders Dizziness	7.7% 1/13 • Number of events 1 Regular investigator assessment, regular laboratory testing, and self-reporting by subjects.
General disorders Fatigue	15.4% 2/13 • Number of events 2 Regular investigator assessment, regular laboratory testing, and self-reporting by subjects.
General disorders Insomnia	15.4% 2/13 • Number of events 2 Regular investigator assessment, regular laboratory testing, and self-reporting by subjects.
Psychiatric disorders Personality change	7.7% 1/13 • Number of events 1 Regular investigator assessment, regular laboratory testing, and self-reporting by subjects.

Additional Information

Valerie Parks, RN

UNM Comprehensive Cancer Center

Phone: 505-925-0390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place