Anxiety DisorderPhase 2NCT00546624
GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)
A Phase 2 study testing MK0777 in people with Anxiety Disorder, run by Merck Sharp & Dohme LLC.
Trial summary
This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- MK0777
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Feb 2003
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been diagnosed with Generalized Anxiety Disorder
- Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study
Who cannot join
- History of drug or alcohol abuse
- Have previously participated in another study using MK0777
About this study
This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder.
This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
- Conditions
- Anxiety Disorder
- Being tested
- MK0777
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0777Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startNov 2002
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546624
- Sponsor's protocol ID
- 0777-026
- Other IDs
- 2007_632
- Status last verified
- Oct 2015
- First submitted
- 17 Oct 2007
- Last updated
- 2 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)
- ClinicalTrials.gov ID
- NCT00546624
- Acronym / sponsor ID
- 0777-026
- Conditions
- Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 19 Oct 2007 (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.
This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment of patients with generalized anxiety disorder.
This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have been diagnosed with Generalized Anxiety Disorder
- Women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study
Key exclusion criteria (2 listed)
- History of drug or alcohol abuse
- Have previously participated in another study using MK0777
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 |
|---|---|---|
| MK0777 | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Nov 2015.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK0777 in people with Anxiety Disorder, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 2 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
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 2 Nov 2015.