NCT01890616

Brief Summary

In this research study the investigators want to screen Duchenne Muscular Dystrophy (DMD) patients for signs and symptoms of constipation in patients over 18. The investigators hypothesized:

  • DMD patients have a high prevalence of constipation than in the general population.
  • Prevalence of constipation will increase with age and with worsening functional status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

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

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

June 26, 2013

Last Update Submit

September 11, 2020

Conditions

ConstipationDMD

Outcome Measures

Primary Outcomes (1)

  • GI transit times

    Gi transit times will be computed by an investigator.

    up to 5 days

Study Arms (1)

Motility

This arm will ingest the SmartPill.

Device: SmartPill ingestion

Interventions

SmartPill ingestionDEVICE

The participant would ingest the SmartPill and wear the data receiver for up to 5 days.

Motility

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DMD patients 5-18 yr of age who are seen in a large interdisciplinary DMD center.

You may qualify if:

  • Patients with a diagnosis of Duchenne Muscular Dystrophy (based on clinical presentation and verified by compatible muscle biopsy or known dystrophin gene mutation).
  • Age greater than or equal to 18 years old

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ajay Kaul, MD

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 2, 2013

Study Start

May 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

US(1)