Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women

Depomed

Status and phase: Completed; Phase 3

Conditions: Hot Flashes

Treatments: Drug: Gabapentin Extended Release; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080300

81-0064

Details and patient eligibility

About

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women

Full description

The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (600mg AM, 1200mg PM), compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women at weeks 4 & 12 of the efficacy treatment period, compared with baseline.

Enrollment: 600 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 moderate to severe hot flashes
• Patients must be able to sign the informed consent
• Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary

Other inclusions apply.

Exclusion criteria

• 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.
• Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms

Other exclusions apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Gabapentin Extended Release

Experimental group

Description:

Active treatment

Treatment:

Drug: Gabapentin Extended Release

Placebo

Other group

Description:

Placebo

Treatment:

Drug: Placebo