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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.
This study aims to explore whether short-term measures of eating behavior can be related to later, longer-term weight loss. In a double-blind, randomized fashion, participants will be asked to take study medication for three weeks: one week of phentermine and two weeks of placebo. At the end of the first and third weeks, participants will be asked to participate in a range of eating behavior studies. Following this three-week, double-blind phase, participants will be offered 6 months of open treatment for weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 37.5 mg Phentermine daily for 7 days | Experimental | In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo. Other names for phentermine: adipex ionamin |
|
| Placebo (for phentermine 37.5mg) | Placebo Comparator | In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phentermine | Drug | After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Food Intake | 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. | one week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurel Mayer, MD | Columbia University Medical Center/New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New York State Psychiatric Institute at Columbia University Medical Center | New York | New York | 10032 | United States |
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13 of the 37 participants were randomized. Of those not randomized, 18 did not meet inclusion criteria and 6 chose not to participate.
37 patients were screened for eligibility between July 2012 and July 2013 at an academic medical center in New York City, NY.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 37.5 mg Phentermine First, Then 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Food Intake | 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. | 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). | Posted | Mean | Standard Deviation | kcal | one week |
|
One week for each study intervention (phentermine or placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 37.5 mg Phentermine | This describes all participants who received 37.5mg phentermine for one week. Other names for phentermine: adipex ionamin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laurel Mayer | New York State Psychiatric Institute | 646-774-8067 | 646 | lsm16@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010645 | Phentermine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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|
| placebo | Drug | Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration. |
|
|
| Placebo First, Then 37.5mg Phentermine |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo (for Phentermine 37.5mg) | 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. |
|
|
|
| 0 |
| 13 |
| 9 |
| 13 |
| EG001 | Placebo | This group refers to all participants who received Placebo. | 0 | 13 | 8 | 13 |
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| feeling drowsy or sleepy | Nervous system disorders | Systematic Assessment |
|
| increased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| trouble concentrating | Nervous system disorders | Systematic Assessment |
|
| irregular heartbeat | Cardiac disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
|
| decreased appetite | Gastrointestinal disorders | Systematic Assessment |
|
| tremor | Nervous system disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| lightheaded upon standing | Nervous system disorders | Systematic Assessment |
|
| difficulty sleeping | Nervous system disorders | Systematic Assessment |
|
| sour taste | Gastrointestinal disorders | Systematic Assessment |
|
| increased urination | Renal and urinary disorders | Systematic Assessment |
|
| shortness of breath | Cardiac disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D002241 | Carbohydrates |