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Effects of Botox in Obstructed Defecation Syndrome

NCT02160288 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-05-12

Study results available
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Summary

The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve symptoms of constipation in obstructed defecation syndrome (ODS).

Conditions

  • Obstructed Defecation Syndrome (ODS)

Interventions

DRUG

Botulinum Toxin-A

100 Units diluted in a 5 cc syringe at a concentration of 20U/mL

DRUG

Normal Saline

Dispensed in a 5 cc syringe

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Liliana Bordeianou, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-06-11
Completion
2019-06-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02160288 on ClinicalTrials.gov