NCT00511953

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

8 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

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

August 2, 2007

Last Update Submit

June 6, 2011

Conditions

Hot Flashes

Keywords

Hot flashesHot flushesPostmenopausal symptoms

Outcome Measures

Primary Outcomes (1)

  • 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

    24hrs

Secondary Outcomes (1)

  • CGIC and PGIC evaluated prior to the start of 24- hour blood samples at week 6 and week 12 visits.

    12 wks

Study Arms (2)

Gabapentin ER

ACTIVE COMPARATOR

Active drug, Gabapentin extended release

Drug: Gabapentin Extended Release tabletsDrug: Gabapentin

Sugar Pill

PLACEBO COMPARATOR

Comparator arm is Placebo

Drug: Gabapentin Extended Release tabletsDrug: Gabapentin

Interventions

Gabapentin Extended Release tabletsDRUG

1800mg

Gabapentin ERSugar Pill
GabapentinDRUG

1800mg

Gabapentin ERSugar Pill

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Burbank, California, United States

Location

Unknown Facility

DeLand, Florida, United States

Location

Unknown Facility

Port Orange, Florida, United States

Location

Unknown Facility

Shawnee, Kansas, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Hackensack, New Jersey, United States

Location

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (1)

  • 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.

    PMID: 22775354DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 2, 2007

First Posted

August 6, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

February 1, 2008

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(8)