Sodium Tungstate in Obesity (TROTA-1)

H

Hospital Clinic of Barcelona

Status and phase

Completed
Phase 2

Conditions

Obesity

Treatments

Drug: Sodium Tungstate
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00555074
TROTA-1
EudraCT: 2006-000567-28

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of sodium tungstate versus placebo in patients with obesity (grade I and II).

Enrollment

44 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • BMI: 30-39.9 Kg/m2
  • In case of male gender, 18 to 65 years old
  • In case of female gender, diagnosis of menopause
  • Body weight changes < 3 kg in the last 3 months
  • In case of arterial hypertension or dyslipemia, no changes in dose in the last 2 months

Exclusion criteria

  • In case of female gender, absence of menopause
  • Evidence of secondary causes of obesity
  • Diabetes, type II
  • Concomitant treatment with drugs affecting body weight
  • Previous surgical intervention of obesity

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

44 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Sodium Tungstate
Treatment:
Drug: Sodium Tungstate
2
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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