ObesityPhase 2NCT00709371
Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
A Phase 2 study testing Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day in people with Obesity, run by Orexigen Therapeutics, Inc at 20 sites in United States.
Trial summary
The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 729 participants
- Where
- 20 sitesUnited States
- Study dates
- Jul 2008to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subjects, 18 to 65 years of age
- Have body mass index (BMI) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated obesity, and BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and dyslipidemia and/or controlled hypertension
- Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to screening
- Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers and clonidine. Medical regimen must be stable for at least 6 weeks prior to randomization
- Triglycerides <400 mg/dL. Medications for treatment of dyslipidemia are allowed with the exception of cholestyramine and cholestypol as long as medical regimen has been stable for at least 6 weeks prior to randomization
- No clinically significant laboratory abnormalities
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- Negative urine drug screen
- Negative serum pregnancy test in women of child-bearing potential
- Women of child-bearing potential must be non-lactating, and agree to use acceptable contraception throughout the study period and for 30 days after discontinuation of study drug
- Able to comply with all required study procedures and schedule
- Able to speak and read English
- Willing and able to give written informed consent
Who cannot join
- Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, polycystic ovary syndrome)
- Serious medical condition
- History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer.
- History of suicide attempt or serious psychiatric illness
- History of Major Depressive Disorder within the past 2 years
- In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization
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- Type I or Type II diabetes
- History of alcohol or drug abuse or dependence as determined by the Investigator within 1 year prior to randomization
- History of surgical or device (e.g. gastric banding) intervention for obesity
- History of seizures or predisposition to seizures
- History of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide
- History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran) within previous 12 months
- History of nephrolithiasis (renal calculi)
- Loss or gain of more than 4.0 kg within 3 months prior to randomization
- Women of child bearing potential not adhering to a medically acceptable form of contraception
- Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Washington Center for Weight Management and Research
Arlington, Virginia, 22201
CSRA Partners in Health, Inc.
Augusta, Georgia, 30909
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Nutrition and Weight Management Center, Boston Medical Center
Boston, Massachusetts, 02118
Internal Medicine Associates of Charlotte
Charlotte, North Carolina, 28277
Radiant Research, Chicago
Chicago, Illinois, 60610
The Cooper Institute
Dallas, Texas, 75230
Center for Human Nutrition/UCD
Denver, Colorado, 80220
Welborn Clinic
Evansville, Indiana, 47713
SelfCenter, PC
Fairhope, Alabama, 36532
Summit Research Network (Michigan), Inc.
Farmington Hills, Michigan, 48336
Nutrition and Metabolic Research
La Jolla, California, 92037
Miami Research Associates
Miami, Florida, 33143
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Center for Nutrition and Metabolic Disorders, University of Nevada School of Medicine
Reno, Nevada, 89557
Summit Research Network (Seattle), LLC.
Seattle, Washington, 98104
FutureCare Studies
Springfield, Massachusetts, 01103
Mercy Health Research
St Louis, Missouri, 63141
Behavioral Medical Research
Staten Island, New York, 10305
About this study
Official title: A Phase IIB, Multi-Center, Dose-Parallel, Randomized, Double-Blind, Monotherapy and Placebo-Controlled Safety and Efficacy Study of Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity.
- Conditions
- Obesity
- Being tested
- Zonisamide SR placebo/ bupropion SR placebo, Zonisamide SR placebo/ bupropion SR 360 mg/day, Zonisamide SR 120 mg/day/ bupropion SR placebo, Zonisamide SR 360 mg/day/ bupropion SR placebo, Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day
- Keywords
- obesity, zonisamide, bupropion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide SR placebo/ bupropion SR placeboDrug
2 placebo combination tablets twice daily for 16 weeks (maintenance period)
Zonisamide SR placebo/ bupropion SR 360 mg/dayDrug
2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide SR 120 mg/day/ bupropion SR placeboDrug
2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide SR 360 mg/day/ bupropion SR placeboDrug
2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide SR 120 mg/day/ bupropion SR 360 mg/dayDrug
2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
Zonisamide SR 360 mg/day/ bupropion SR 360 mg/dayDrug
2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Combination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release Receives: Drug: Zonisamide SR placebo/ bupropion SR placebo |
| Bupropion 360 | Active comparator | Combination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release Receives: Drug: Zonisamide SR placebo/ bupropion SR 360 mg/day |
| Zonisamide 120 | Active comparator | Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release Receives: Drug: Zonisamide SR 120 mg/day/ bupropion SR placebo |
| Zonisamide 360 | Active comparator | Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release Receives: Drug: Zonisamide SR 360 mg/day/ bupropion SR placebo |
| Zonisamide 120/Bupropion 360 | Experimental | Combination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release Receives: Drug: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day |
| Zonisamide 360/Bupropion 360 | Experimental | Combination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release Receives: Drug: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in total body weight
Measured: from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Acampora, MD, Principal investigator, Internal Medicine Associates of CharlotteCaroline Apovian, MD, Principal investigator, Nutrition and Weight Management CenterJames Bergthold, MD, Principal investigator, Summit Research Network (Oregon), Inc.Joseph Cleaver, MD, Principal investigator, The Cooper InstituteAdnan Dahdul, MD, Principal investigator, FutureCare StudiesKen Fujioka, MD, Principal investigator, Nutrition and Metabolic ResearchJeffrey Geohas, MD, Principal investigator, Radiant Research, ChicagoMark Graves, MD, Principal investigator, Welborn Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709371
- Sponsor's protocol ID
- ZB-202
- Status last verified
- Nov 2012
- First submitted
- 29 Jun 2008
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB, Multi-Center, Dose-Parallel, Randomized, Double-Blind, Monotherapy and Placebo-Controlled Safety and Efficacy Study of Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
- ClinicalTrials.gov ID
- NCT00709371
- Acronym / sponsor ID
- ZB-202
- Conditions
- Obesity
- Keywords
- obesity, zonisamide, bupropion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Zonisamide SR placebo/ bupropion SR placeboCombination tablet containing Zonisamide SR placebo plus bupropion SR placebo SR = Sustained Release |
| Bupropion 360 | Active comparator | Drug: Zonisamide SR placebo/ bupropion SR 360 mg/dayCombination tablet containing Zonisamide SR placebo plus bupropion SR 360 mg/day; SR = Sustained Release |
| Zonisamide 120 | Active comparator | Drug: Zonisamide SR 120 mg/day/ bupropion SR placeboCombination tablet containing Zonisamide SR 120 mg/day plus bupropion SR placebo; SR = Sustained Release |
| Zonisamide 360 | Active comparator | Drug: Zonisamide SR 360 mg/day/ bupropion SR placeboCombination tablet containing Zonisamide SR 360 mg/day plus bupropion SR placebo; SR = Sustained Release |
| Zonisamide 120/Bupropion 360 | Experimental | Drug: Zonisamide SR 120 mg/day/ bupropion SR 360 mg/dayCombination tablet containing Zonisamide SR 120 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release |
| Zonisamide 360/Bupropion 360 | Experimental | Drug: Zonisamide SR 360 mg/day/ bupropion SR 360 mg/dayCombination tablet containing Zonisamide SR 360 mg/day plus bupropion SR 360 mg/day; SR = Sustained Release |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female or male subjects, 18 to 65 years of age
- Have body mass index (BMI) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated obesity, and BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and dyslipidemia and/or controlled hypertension
- Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to screening
- Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers and clonidine. Medical regimen must be stable for at least 6 weeks prior to randomization
- Triglycerides <400 mg/dL. Medications for treatment of dyslipidemia are allowed with the exception of cholestyramine and cholestypol as long as medical regimen has been stable for at least 6 weeks prior to randomization
Key exclusion criteria (16 listed)
- Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, polycystic ovary syndrome)
- Serious medical condition
- History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer.
- History of suicide attempt or serious psychiatric illness
- History of Major Depressive Disorder within the past 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamide SR placebo/ bupropion SR placebo2 placebo combination tablets twice daily for 16 weeks (maintenance period) | Drug | Placebo |
| Zonisamide SR placebo/ bupropion SR 360 mg/day2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period) | Drug | Bupropion 360 |
| Zonisamide SR 120 mg/day/ bupropion SR placebo2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period) | Drug | Zonisamide 120 |
| Zonisamide SR 360 mg/day/ bupropion SR placebo2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period) | Drug | Zonisamide 360 |
| Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period) | Drug | Zonisamide 120/Bupropion 360 |
| Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period) | Drug | Zonisamide 360/Bupropion 360 |
Primary outcome
Percentage change in total body weight
Time frame: from baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Acampora, MD principal investigator
Internal Medicine Associates of Charlotte
Caroline Apovian, MD principal investigator
Nutrition and Weight Management Center
James Bergthold, MD principal investigator
Summit Research Network (Oregon), Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day in people with Obesity, run by Orexigen Therapeutics, Inc at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in total body weight (time frame: from baseline to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.