Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Studying the Effects of Phentermine on Eating Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01886937
Recruitment Status : Completed
First Posted : June 26, 2013
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Obesity
Interventions Drug: Phentermine
Drug: placebo
Enrollment 13
Recruitment Details 37 patients were screened for eligibility between July 2012 and July 2013 at an academic medical center in New York City, NY.
Pre-assignment Details 13 of the 37 participants were randomized. Of those not randomized, 18 did not meet inclusion criteria and 6 chose not to participate.
Arm/Group Title 37.5 mg Phentermine Daily for 7 Days First,Followed by Placebo Placebo (for Phentermine 37.5mg) First, Followed by Phentermin
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 7 6
Completed 7 6
Not Completed 0 0
Arm/Group Title 37.5 mg Phentermine First, Then Placebo Placebo First, Then 37.5mg Phentermine Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 7 6 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
6
 100.0%
13
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 13 participants
45  (14) 37  (16) 42  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Female
6
  85.7%
6
 100.0%
12
  92.3%
Male
1
  14.3%
0
   0.0%
1
   7.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
Hispanic or Latino
2
  28.6%
1
  16.7%
3
  23.1%
Not Hispanic or Latino
5
  71.4%
5
  83.3%
10
  76.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  14.3%
1
  16.7%
2
  15.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  57.1%
3
  50.0%
7
  53.8%
White
2
  28.6%
2
  33.3%
4
  30.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 6 participants 13 participants
7 6 0
1.Primary Outcome
Title Food Intake
Hide Description 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.
Time Frame one week
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 37.5 mg Phentermine Daily for 7 Days Placebo (for Phentermine 37.5mg)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: kcal
849  (572) 975  (504)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 37.5 mg Phentermine Daily for 7 Days, Placebo (for Phentermine 37.5mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame One week for each study intervention (phentermine or placebo).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 37.5 mg Phentermine Placebo
Hide Arm/Group Description

This describes all participants who received 37.5mg phentermine for one week.

Other names for phentermine:

adipex ionamin

This group refers to all participants who received Placebo.
All-Cause Mortality
37.5 mg Phentermine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
37.5 mg Phentermine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
37.5 mg Phentermine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/13 (69.23%)   8/13 (61.54%) 
Cardiac disorders     
irregular heartbeat   0/13 (0.00%)  1/13 (7.69%) 
shortness of breath   0/13 (0.00%)  1/13 (7.69%) 
Gastrointestinal disorders     
constipation   3/13 (23.08%)  4/13 (30.77%) 
nausea   2/13 (15.38%)  1/13 (7.69%) 
increased appetite   0/13 (0.00%)  2/13 (15.38%) 
diarrhea   0/13 (0.00%)  1/13 (7.69%) 
decreased appetite   5/13 (38.46%)  3/13 (23.08%) 
sour taste   1/13 (7.69%)  0/13 (0.00%) 
General disorders     
dry mouth   5/13 (38.46%)  3/13 (23.08%) 
Nervous system disorders     
headache   2/13 (15.38%)  3/13 (23.08%) 
feeling drowsy or sleepy   1/13 (7.69%)  1/13 (7.69%) 
trouble concentrating   2/13 (15.38%)  1/13 (7.69%) 
tremor   2/13 (15.38%)  1/13 (7.69%) 
dizziness   2/13 (15.38%)  1/13 (7.69%) 
lightheaded upon standing   2/13 (15.38%)  1/13 (7.69%) 
difficulty sleeping   3/13 (23.08%)  4/13 (30.77%) 
Renal and urinary disorders     
increased urination   2/13 (15.38%)  3/13 (23.08%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Laurel Mayer
Organization: New York State Psychiatric Institute
Phone: 646-774-8067 ext 646
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01886937     History of Changes
Other Study ID Numbers: 6415
First Submitted: June 24, 2013
First Posted: June 26, 2013
Results First Submitted: March 28, 2017
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017