NCT00364871

Brief Summary

The purpose of this study is to determine the efficacy and safety of 3 combinations of naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Apr 2005

Typical duration for phase_2 obesity

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

1.9 years

First QC Date

August 14, 2006

Last Update Submit

April 18, 2008

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Percentage change in total body weight

    baseline to week 24

Study Arms (7)

1

EXPERIMENTAL

Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day)

Drug: naltrexone and bupropion SR

2

EXPERIMENTAL

Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day)

Drug: naltrexone and bupropion SR

3

ACTIVE COMPARATOR

Bupropion SR (400 mg/day)

Drug: naltrexone and bupropion SR

4

ACTIVE COMPARATOR

Naltrexone (48 mg/day)

Drug: naltrexone and bupropion SR

5

PLACEBO COMPARATOR

B-Placebo plus N-Placebo

Drug: naltrexone and bupropion SR

6

PLACEBO COMPARATOR

B-Placebo plus N-Placebo

Drug: naltrexone and bupropion SR

7

EXPERIMENTAL

Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day)

Drug: naltrexone and bupropion SR

Interventions

naltrexone and bupropion SRDRUG

naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day

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Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female and male subjects, 18 to 60 years of age
  • Have body mass index (BMI) of 30 to 40 kg/m2
  • Free from clinically significant illness or disease as determined by medical history and physical examination
  • Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to baseline
  • Normotensive (systolic \<140 mm Hg; diastolic \<90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers, beta-blockers and clonidine. Medical regimen must be stable for at least 6 weeks
  • LDL cholesterol \< 190 mg/dL and triglycerides \< 400 mg/dL. Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks
  • No clinically significant abnormality of serum albumin, blood urea nitrogen, creatinine, calcium and phosphorus
  • Bilirubin, ALT and AST within 1.5 x ULN
  • No clinically significant abnormality of hematocrit, white blood cell count, white cell differential, or platelets
  • Fasting glucose less than 140 mg/dL on no hypoglycemic agents
  • No clinically significant abnormality on urinalysis
  • TSH within 1.5 x ULN, normal T3, if TSH below lower limit of normal
  • Negative serum pregnancy test in women with intact uterus
  • Score \< 11 for depression and score \< 11 for anxiety on Hospital Anxiety and Depression (HAD) Scale
  • ECG: no clinically significant abnormality
  • +4 more criteria

You may not qualify if:

  • Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
  • Serious medical condition or medical condition that limits participation in the prescribed exercise program: (e.g. unstable cardiovascular disease including congestive heart failure, angina pectoris, and myocardial infarction; stroke; claudication; acute limb ischemia; acute renal or hepatic disorder; renal, hepatic or respiratory insufficiency)
  • Active malignancy or history of malignancy (other than non-melanoma skin cancer or surgically cured cervical cancer) within 5 years of enrollment
  • Serious psychiatric condition (e.g., any history of bipolar disorder, psychosis, suicidal attempt or post-partum depression; a history of major depression, suicidal ideation or antidepressant use within 1 year)
  • Type I or Type II diabetes mellitus requiring pharmacotherapy
  • Excluded concomitant medications: anorectic agents; weight loss agents; dietary supplements to promote muscle building, enhance mood, or reduce appetite; adrenergic blockers; beta blockers; anti-psychotic agents; clonidine; theophylline; cimetidine; oral corticosteroids; anti-depressant; topiramate; Depo-Provera®, smoking cessation agents; frequent, known use of opioid or opioid-like analgesics
  • History of surgical intervention for obesity
  • History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, significant head trauma, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
  • History of bulimia or anorexia nervosa
  • History of drug or alcohol abuse within 5 years
  • History of treatment with bupropion, or naltrexone within 12 months
  • History of hypersensitivity to bupropion, or naltrexone
  • Use of drugs, herbs, or dietary supplements known to significantly affect body weight within one month of baseline
  • Use of investigational drug, device or procedure within 90 days
  • Participation in any previous clinical trial conducted by Orexigen Therapeutics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Scripps Clinic Del mar

San Diego, California, 92130, United States

Location

CSRA Partners in Health, Inc

Augusta, Georgia, 30909, United States

Location

UK Clinical Research Organization

Lexington, Kentucky, 40536, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Center for Nutrition and Preventive Medicine

Charlotte, North Carolina, 28211, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MUSC Weight Management Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Frank Greenway, MD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 16, 2006

Study Start

April 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(7)