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A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men

Phase 3
18 Years
Not Enrolling
Hot Flashes, Prostate Cancer

Thank you

Trial Information

A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men


- Determine the effectiveness of gabapentin in managing hot flashes in men with prostate

- Determine the response of patients to this drug.

- Determine the toxicity of this drug in these patients.

- Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and
duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are
randomized to one of four treatment arms.

All patients are observed for 7 days prior to drug administration in order to collect
baseline hot flash information.

- Arm I: Patients receive oral gabapentin once daily on days 1-28.

- Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days

- Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days
8-14, and three times daily on days 15-28.

- Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms

Patients in all arms may continue therapy with gabapentin for an additional 8 weeks.

Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks.

Patients are followed at 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this
study within 1 year.

Inclusion Criteria


- Diagnosis of prostate cancer

- Received or are currently receiving androgen ablation therapy

- Hot flashes for at least 1 month

- At least 14 times per week and severe enough to require therapeutic intervention



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- At least 6 months


- Not specified


- Not specified


- Creatinine < 1.5 times upper limit of normal over the past 2 years


- No prior allergic or adverse reaction to gabapentin


Biologic therapy:

- Not specified


- At least 4 weeks since prior antineoplastic chemotherapy

- No concurrent antineoplastic chemotherapy

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior androgens, estrogens, or progestational agents

- No concurrent androgens, estrogens, or progestational agents

- Concurrent hormonal therapy allowed if on stable dose for at least 4 weeks and plan
to continue therapy throughout study


- Not specified


- Not specified


- No prior gabapentin

- No other concurrent treatment for hot flashes

- Concurrent antidepressants allowed if on stable dose for at least 1 month and plan to
continue therapy throughout study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Hot flash reduction by diary scores at 4 weeks

Outcome Time Frame:

5 weeks from study entry

Safety Issue:


Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

December 2001

Completion Date:

April 2007

Related Keywords:

  • Hot Flashes
  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • hot flashes
  • Prostatic Neoplasms
  • Hot Flashes



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