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

2014-08-27 03:15:29 | BioPortfolio

Summary

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hot Flashes

Intervention

Gabapentin Extended Release

Location

Birmingham
Alabama
United States

Status

Completed

Source

Depomed

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

Clinical Trials [1246 Associated Clinical Trials listed on BioPortfolio]

Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) 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.

Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) 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.

Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) 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

Gabapentin for the Treatment of Hot Flashes in Menopausal Women

The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized...

Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors

Overall Objectives: The overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cance...

PubMed Articles [5692 Associated PubMed Articles listed on BioPortfolio]

Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial.

To evaluate whether extended-release gabapentin is more effective than placebo among women with vulvodynia.

Extended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis.

To compare the estimated glomerular filtration rate (eGFR) at 12 months together with other outcomes among adult kidney transplant recipients (KTRs) who received extended release, once daily tacrolim...

Extended release bupivacaine formulations for postoperative analgesia: an update.

New formulations of local anesthetics with sustained release and longer duration of action are being developed to improve patient outcomes following surgery. This review summarizes the efficacy and sa...

Preoperative Gabapentin Administration Improves Acute Postoperative Analgesia in Patients Undergoing Craniotomy: A Randomized Controlled Trial.

Gabapentin is an adjuvant antiepileptic agent and helps to reduce acute postoperative pain in several surgery settings. However, the effect of gabapentin on postoperative pain from suboccipital or sub...

A Randomized, Double-Blind Study of SHP465 Mixed Amphetamine Salts Extended-Release in Adults With ADHD Using a Simulated Adult Workplace Design.

Evaluate the efficacy, duration of effect, and tolerability of SHP465 mixed amphetamine salts (MAS) extended-release versus placebo and immediate-release MAS (MAS IR) in adults with attention-deficit/...

Medical and Biotech [MESH] Definitions

Hydrophilic contact lenses worn for an extended period or permanently.

A sudden, temporary sensation of heat predominantly experienced by some women during MENOPAUSE. (Random House Unabridged Dictionary, 2d ed)

Investigative technique commonly used during ELECTROENCEPHALOGRAPHY in which a series of bright light flashes or visual patterns are used to elicit brain activity.

A malpresentation of the FETUS at near term or during OBSTETRIC LABOR with the fetal cephalic pole in the fundus of the UTERUS. There are three types of breech: the complete breech with flexed hips and knees; the incomplete breech with one or both hips partially or fully extended; the frank breech with flexed hips and extended knees.

A hypothalamic tripeptide, enzymatic degradation product of OXYTOCIN, that inhibits the release of MELANOCYTE-STIMULATING HORMONES.

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