Trial Outcomes & Findings for Studying the Effects of Phentermine on Eating Behavior (NCT NCT01886937)

Last Updated: 2017-07-31

Results Overview

The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

one week

Results posted on

2017-07-31

Participant Flow

37 patients were screened for eligibility between July 2012 and July 2013 at an academic medical center in New York City, NY.

13 of the 37 participants were randomized. Of those not randomized, 18 did not meet inclusion criteria and 6 chose not to participate.

Participant milestones

Participant milestones
Measure	37.5 mg Phentermine Daily for 7 Days First,Followed by Placebo In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo. Other names for phentermine: adipex ionamin Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.	Placebo (for Phentermine 37.5mg) First, Followed by Phentermin In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days. placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
Overall Study STARTED	7	6
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studying the Effects of Phentermine on Eating Behavior

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	37.5 mg Phentermine First, Then Placebo n=7 Participants In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo. Other names for phentermine: adipex ionamin Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.	Placebo First, Then 37.5mg Phentermine n=6 Participants In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days. placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.	Total n=13 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	7 Participants n=5 Participants	6 Participants n=7 Participants	13 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	45 years STANDARD_DEVIATION 14 • n=5 Participants	37 years STANDARD_DEVIATION 16 • n=7 Participants	42 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: one week

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

The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.

Outcome measures

Outcome measures
Measure	37.5 mg Phentermine Daily for 7 Days n=13 Participants In this arm, participants receive 37.5mg phentermine for one week . Other names for phentermine: adipex ionamin Phentermine: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.	Placebo (for Phentermine 37.5mg) n=13 Participants In this arm, participants receive Placebo (for 37.5mg phentermine) for 7 days. placebo: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
Food Intake	849 kcal Standard Deviation 572	975 kcal Standard Deviation 504

Adverse Events

37.5 mg Phentermine

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Laurel Mayer

New York State Psychiatric Institute

Phone: 646-774-8067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	37.5 mg Phentermine n=13 participants at risk This describes all participants who received 37.5mg phentermine for one week. Other names for phentermine: adipex ionamin	Placebo n=13 participants at risk This group refers to all participants who received Placebo.
Nervous system disorders headache	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	23.1% 3/13 • One week for each study intervention (phentermine or placebo).
Gastrointestinal disorders constipation	23.1% 3/13 • One week for each study intervention (phentermine or placebo).	30.8% 4/13 • One week for each study intervention (phentermine or placebo).
Gastrointestinal disorders nausea	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Nervous system disorders feeling drowsy or sleepy	7.7% 1/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Gastrointestinal disorders increased appetite	0.00% 0/13 • One week for each study intervention (phentermine or placebo).	15.4% 2/13 • One week for each study intervention (phentermine or placebo).
Nervous system disorders trouble concentrating	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Cardiac disorders irregular heartbeat	0.00% 0/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Gastrointestinal disorders diarrhea	0.00% 0/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
General disorders dry mouth	38.5% 5/13 • One week for each study intervention (phentermine or placebo).	23.1% 3/13 • One week for each study intervention (phentermine or placebo).
Gastrointestinal disorders decreased appetite	38.5% 5/13 • One week for each study intervention (phentermine or placebo).	23.1% 3/13 • One week for each study intervention (phentermine or placebo).
Nervous system disorders tremor	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Nervous system disorders dizziness	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Nervous system disorders lightheaded upon standing	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).
Nervous system disorders difficulty sleeping	23.1% 3/13 • One week for each study intervention (phentermine or placebo).	30.8% 4/13 • One week for each study intervention (phentermine or placebo).
Gastrointestinal disorders sour taste	7.7% 1/13 • One week for each study intervention (phentermine or placebo).	0.00% 0/13 • One week for each study intervention (phentermine or placebo).
Renal and urinary disorders increased urination	15.4% 2/13 • One week for each study intervention (phentermine or placebo).	23.1% 3/13 • One week for each study intervention (phentermine or placebo).
Cardiac disorders shortness of breath	0.00% 0/13 • One week for each study intervention (phentermine or placebo).	7.7% 1/13 • One week for each study intervention (phentermine or placebo).