Feeling AnxiousPhase 2NCT01675986
Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
A Phase 2 study testing hydroxyzine, Pregabalin and Lactose in people with Feeling Anxious, run by Poitiers University Hospital at 1 site in France.
Trial summary
The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Feeling Anxious
- What is being tested?
- hydroxyzine, Pregabalin and Lactose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Nov 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 75 years
- Patient schedules for insertion of long-lasting intravenous device
Who cannot join
- History of previous insertion of long-lasting intravenous device or central intravenous catheter
- long term treatment of gabapentin or pregabalin
- Hypersensitivity to pregabalin or any of the excipients
- Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
- Patient at risk of glaucoma e
- Patient at risk for urinary retention
Show all 13Show fewer
- Patient severe respiratory failure
- Patient at the general condition not too corrupted (ASA IV)
- Renal failure with creatinin clearance < 30 ml / min
- Patient not affiliated to Social Security
- Pregnant or lactating
- Patients in emergency situations
- Inpatient without consent
Trial locations and contacts
1 site in 1 country.
About this study
The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies.
Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable.
Read more
Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties
The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.
- Conditions
- Feeling Anxious
- Being tested
- hydroxyzine, Pregabalin, Lactose
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyzineDrug
75 mg
PregabalinDrug
150 mg
LactoseDrug
4 g
| Study group | Role | What they receive |
|---|---|---|
| Pregabaline | Experimental | Groups PREGABALINE : 150 mg de LYRICA® Receives: Drug: Pregabalin |
| Hydroxyzine | Experimental | Groups HYDROXYZINE : 75 mg d'ATARAX® Receives: Drug: hydroxyzine |
| Lactose | Placebo comparator | Groups placebo : 4 g de lactose Receives: Drug: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy treatment
anxiety score VAS: 0 to 100
Secondary outcomes (1)
Efficacy of pregabaldin
anxiety score VAS:0 to 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeling AnxiousStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand DEBAENE, MD, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675986
- Sponsor's protocol ID
- GABAPAC
- Status last verified
- Oct 2016
- First submitted
- 7 Feb 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
- ClinicalTrials.gov ID
- NCT01675986
- Acronym / sponsor ID
- GABAPAC
- Conditions
- Feeling Anxious
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Primary completion
- Nov 2014 (actual)
- First posted
- 30 Aug 2012 (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 insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies.
Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable.
Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties
The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregabaline | Experimental | Drug: PregabalinGroups PREGABALINE : 150 mg de LYRICA® |
| Hydroxyzine | Experimental | Drug: hydroxyzineGroups HYDROXYZINE : 75 mg d'ATARAX® |
| Lactose | Placebo comparator | Drug: LactoseGroups placebo : 4 g de lactose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged from 18 to 75 years
- Patient schedules for insertion of long-lasting intravenous device
Key exclusion criteria (13 listed)
- History of previous insertion of long-lasting intravenous device or central intravenous catheter
- long term treatment of gabapentin or pregabalin
- Hypersensitivity to pregabalin or any of the excipients
- Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
- Patient at risk of glaucoma e
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 |
|---|---|---|
| hydroxyzine75 mg | Drug | Hydroxyzine |
| Pregabalin150 mg | Drug | Pregabaline |
| Lactose4 g | Drug | Lactose |
Primary outcome
Efficacy treatment
anxiety score VAS: 0 to 100
1 secondary outcome
Efficacy of pregabaldin
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 11 Oct 2016.
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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.
Bertrand DEBAENE, MD principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydroxyzine, Pregabalin and Lactose in people with Feeling Anxious, run by Poitiers University Hospital at 1 site in France.
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 13 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 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Efficacy treatment. 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 11 Oct 2016.