NCT00861562

Brief Summary

The purpose of this study was to assess the clinical efficacy and safety of the drug Imescard water smartweed compound pills in the treatment of patients with chronic constipation and hemorrhoidal disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

March 12, 2009

Last Update Submit

March 12, 2009

Conditions

Chronic ConstipationHemorrhoids

Keywords

constipationhemorrhoidswater smartweedRCT

Outcome Measures

Primary Outcomes (1)

  • Reduction in colonic transit time assessed through radiologic technique.

    Day 5 and day 19.

Secondary Outcomes (3)

  • Daily evaluation of constipation and hemorrhoidal symptoms assessed by questionnaires.

    Daily from day 1 to 5 and from day 15 to 19.

  • Health quality improvement assessed by WHOQOL Brief at every followup visit.

    Days 1, 5, 15 and 19.

  • Adverse effects assessed by the investigator, blinded to the intervention, at every followup visit, through physical examination and laboratory exams.

    Days 1, 5, 15 and 19.

Study Arms (2)

Imescard pills/Placebo crossover

ACTIVE COMPARATOR

Patients received Imescard water smartweed composed pills during the first intervention period and placebo during the second, after a 10-day washout period.

Drug: Imescard water smartweed composed pillsDrug: Placebo

Placebo/Imescard pills crossover

ACTIVE COMPARATOR

Patients received placebo during the first intervention period and Imescard water smartweed composed pills during the second, after a 10-day washout period.

Drug: Imescard water smartweed composed pillsDrug: Placebo

Interventions

Imescard water smartweed composed pillsDRUG

01 pill at every 8 hours for 5 days.

Imescard pills/Placebo crossoverPlacebo/Imescard pills crossover
PlaceboDRUG

01 pill at every 8 hours for 5 days, with the exact same appearance as the other intervention.

Imescard pills/Placebo crossoverPlacebo/Imescard pills crossover

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 to 50;
  • chronic constipation diagnosis by the American Association of Gastroentherology (AAG) criteria;
  • clinical diagnosis of first and second degree hemorrhoids;
  • good understanding and collaboration skills;
  • correct fulfilling of the questionnaire at recruiting phase;
  • absence of abnormalities in laboratory exams at recruiting phase;
  • proper use of anticonceptives, in the case of women in fertile age;
  • possibility of abstaining from other drugs (including non-medical ones) other than the intervention during the study, except in case of emergency and with the awareness of the responsible party in the study;
  • signing informed consent form.

You may not qualify if:

  • Pregnant or lactating women;
  • known hypersensitivity to any of the intervention's components;
  • use of alcohol or illicit substances;
  • clinical evidence of immunosuppression;
  • diagnosis of any acute disease in activity or exacerbation of a chronic condition(uncontrolled), such as systemic arterial hypertension, ischemic cardiopathy, angle closure glaucoma, symptomatic prostatic hyperplasia, other concomitant anal disease as fissures, abscesses,fistulas,inflammatory bowel disease or colonic and rectal cancer, as well as any other condition that, in the investigator's opinion, may modify the study results unduly to the intervention being tested or that may put the patient in significant risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

HemorrhoidsConstipation

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

April 1, 2009

Last Updated

March 13, 2009

Record last verified: 2009-03

Locations

BR(1)