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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01890616
Other study ID # 2013-1312
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2013
Est. completion date July 1, 2015

Study information

Verified date September 2020
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The following procedures will take place during the study.

Constipation Assessment:

- The patient will be asked to complete a questionnaire about any symptoms of constipation.

- A physician from the study team will perform an abdominal physical exam

- The patient will have routine x-rays that monitor for spine compression fractures. These films will also be used to assess stool content.

Clinical Information The following information will also be collected during the clinic visit ;

- Age at diagnosis and genetic mutation

- Age at loss of ambulation if applicable

- Medications

- Functional status


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date July 1, 2015
Est. primary completion date July 1, 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- None

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary GI transit times Gi transit times will be computed by an investigator. up to 5 days
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