Hot FlashesPhase 2NCT00511953
Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women
A Phase 2 study testing Gabapentin Extended Release tablets and Gabapentin in people with Hot Flashes, run by Depomed at 8 sites in United States.
Trial summary
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Gabapentin Extended Release tablets and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2007to Feb 2008
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy, postmenopausal women who seek treatment for hot flashes.
- Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
- Patients must be experiencing at least 7 moderate to severe hot flashes per day.
- Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling.
- Other inclusions apply.
Who cannot join
- Patients with hypersensitivity to gabapentin.
- Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
- Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
- Other exclusions apply.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Baltimore, Maryland
Study site
Burbank, California
Study site
DeLand, Florida
Study site
Greenville, South Carolina
Study site
Hackensack, New Jersey
Study site
Port Orange, Florida
Study site
San Antonio, Texas
Study site
Shawnee, Kansas
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.
Read the detailed description
The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.
- Conditions
- Hot Flashes
- Being tested
- Gabapentin Extended Release tablets, Gabapentin
- Keywords
- Hot flashes, Hot flushes, Postmenopausal symptoms
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin Extended Release tabletsDrug
1800mg
GabapentinDrug
1800mg
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin ER | Active comparator | Active drug, Gabapentin extended release Receives: Drug: Gabapentin Extended Release tablets; Drug: Gabapentin |
| Sugar Pill | Placebo comparator | Comparator arm is Placebo Receives: Drug: Gabapentin Extended Release tablets; Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
PD end points are considered as primary outcomes of this study
Measured: 24hrs
Secondary outcomes (1)
CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.
Efficacy variables
Measured: 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Depomed
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511953
- Sponsor's protocol ID
- 81-0056
- Status last verified
- Jun 2011
- First submitted
- 2 Aug 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cowles VE, Gordi T, Hou SY. Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms. Clin Drug Investig. 2012 Sep 1;32(9):593-601. doi: 10.1007/BF03261914.
PubMed 22775354
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00511953
- Acronym / sponsor ID
- 81-0056
- Conditions
- Hot Flashes
- Keywords
- Hot flashes, Hot flushes, Postmenopausal symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- DepomedIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Aug 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.
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women.
Detailed description
The primary objective of this clinical trial is to determine the optimal dose of Gabapentin ER in reducing the number and severity of hot flashes in postmenopausal women. Patients will be randomly assigned to Gabapentin ER or placebo, with a 1 in 4 chance of getting placebo. The total study investigational treatment duration after screening and baseline will be 13 weeks. The primary endpoint of the trial is to compare the number and severity of hot flashes during the investigational treatment compared to baseline. Sleep quality will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin ER | Active comparator | Drug: Gabapentin Extended Release tablets, Drug: GabapentinActive drug, Gabapentin extended release |
| Sugar Pill | Placebo comparator | Drug: Gabapentin Extended Release tablets, Drug: GabapentinComparator arm is Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Generally healthy, postmenopausal women who seek treatment for hot flashes.
- Patients using hormone replacement therapy (HRT) must be willing to discontinue treatment.
- Patients must be experiencing at least 7 moderate to severe hot flashes per day.
- Patient must be willing to commit to 3 (optionally 4) overnight stays at the study site that will include frequent blood sampling.
- Other inclusions apply.
Key exclusion criteria (4 listed)
- Patients with hypersensitivity to gabapentin.
- Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss.
- Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
- Other exclusions apply.
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 |
|---|---|---|
| Gabapentin Extended Release tablets1800mg | Drug | Gabapentin ER, Sugar Pill |
| Gabapentin1800mg | Drug | Gabapentin ER, Sugar Pill |
Primary outcome
Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period
Time frame: 24hrs
PD end points are considered as primary outcomes of this study
1 secondary outcome
CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.
Time frame: 12 wks
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 8 Jun 2011.
- Derived from this study: PubMed 22775354Cowles VE, Gordi T, Hou SY. Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms. Clin Drug Investig. 2012 Sep 1;32(9):593-601. doi: 10.1007/BF03261914.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 Gabapentin Extended Release tablets and Gabapentin in people with Hot Flashes, run by Depomed at 8 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 5 inclusion and 4 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Frequency of moderate to severe hot flashes reported during the corresponding 24- hour blood samples collection period (time frame: 24hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511953, which also lists 1 linked publication.
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 8 Jun 2011.