NCT01485328

Brief Summary

This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

December 16, 2008

Last Update Submit

December 5, 2011

Conditions

Digestive System Disorders

Keywords

DyspepsiaFlatulenceAerophagiaConstipation

Outcome Measures

Primary Outcomes (1)

  • VAS - visual analogue scale

    Single dose 40mL AMARGOL 20 minutes before Dinner - strong meal

    24h

Study Arms (2)

AMARGOL

ACTIVE COMPARATOR

per oral solution 40 mL single dose

Drug: AMARGOL®

Vehicle without active principles

PLACEBO COMPARATOR

per oral solution 40 mL single dose

Drug: AMARGOL®

Interventions

AMARGOL®DRUG

per oral solution, 40 mL single dose

Also known as: AMARGOL, Phytomedicine, Herbal Extracts Mixture
AMARGOLVehicle without active principles

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • healthy volunteers

You may not qualify if:

  • chronic dyspeptics illness chronic congestive cardiac problems
  • pulmonary problems
  • diabetes, thyroid problems
  • pregnancy
  • bowel syndrome
  • hemorrhoids
  • colitis
  • allergies for any formula components.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phytopharm Consulting

Porto Alegre, Rio Grande do Sul, 90130-021, Brazil

Location

MeSH Terms

Conditions

Digestive System DiseasesDyspepsiaFlatulenceAerophagyConstipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Angelo G Chaves, Doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 5, 2011

Study Start

December 1, 2008

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

BR(1)