Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)

October 10, 2017 updated by: GlaxoSmithKline

A Prospective Observational Study for the Psychometric Validation of a Patient-reported Questionnaire in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD). This questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient's perspective. At a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of COPD (AECOPD). This study will evaluate the factor structure, validity, reliability, and responsiveness of the GSK questionnaire in subjects who experience acute exacerbations of their COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
259

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 10178
        • GSK Investigational Site
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 13597
        • GSK Investigational Site
      • Berlin, Germany, 14109
        • GSK Investigational Site
      • Berlin, Germany, 10965
        • GSK Investigational Site
      • Berlin, Germany, 10969
        • GSK Investigational Site
      • Hamburg, Germany, 20357
        • GSK Investigational Site
      • Hamburg, Germany, 22765
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Schwetzingen, Baden-Wuerttemberg, Germany, 68723
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Bayern
      • Bad Woerrishofen, Bayern, Germany, 86825
        • GSK Investigational Site
      • Koetzting, Bayern, Germany, 93444
        • GSK Investigational Site
      • Landsberg, Bayern, Germany, 86899
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81677
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80336
        • GSK Investigational Site
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14469
        • GSK Investigational Site
      • Ruedersdorf, Brandenburg, Germany, 15562
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44787
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53119
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53123
        • GSK Investigational Site
      • Dueren, Nordrhein-Westfalen, Germany, 52349
        • GSK Investigational Site
      • Euskirchen, Nordrhein-Westfalen, Germany, 53879
        • GSK Investigational Site
      • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
        • GSK Investigational Site
      • Luedenscheid, Nordrhein-Westfalen, Germany, 58509
        • GSK Investigational Site
      • Solingen, Nordrhein-Westfalen, Germany, 42651
        • GSK Investigational Site
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
        • GSK Investigational Site
      • Wahlstedt, Schleswig-Holstein, Germany, 23812
        • GSK Investigational Site
  • Italy
    • Campania
      • Caserta, Campania, Italy, 81100
        • GSK Investigational Site
      • Eboli (SA), Campania, Italy, 84025
        • GSK Investigational Site
      • Salerno, Campania, Italy, 84126
        • GSK Investigational Site
      • Telese Terme (BN), Campania, Italy, 82037
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Rozzano (MI), Lombardia, Italy, 20089
        • GSK Investigational Site
    • Puglia
      • Bari, Puglia, Italy, 70124
        • GSK Investigational Site
      • Foggia, Puglia, Italy, 71100
        • GSK Investigational Site
    • Sicilia
      • Palermo, Sicilia, Italy, 90146
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56124
        • GSK Investigational Site
    • Umbria
      • San Martino in Tregnano (Spoleto, PG), Umbria, Italy, 06049
        • GSK Investigational Site
      • San Sisto (PG), Umbria, Italy, 06132
        • GSK Investigational Site
      • Spoleto (PG), Umbria, Italy, 06049
        • GSK Investigational Site
    • Veneto
      • Cittadella (PD), Veneto, Italy, 35013
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35233
        • GSK Investigational Site
      • Huey Town, Alabama, United States, 35023
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • California
      • Rancho Mirage, California, United States, 92270
        • GSK Investigational Site
      • Riverside, California, United States, 92506
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • GSK Investigational Site
      • Fort Collins, Colorado, United States, 80528
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • GSK Investigational Site
      • Hartford, Connecticut, United States, 06106
        • GSK Investigational Site
    • Florida
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32504
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32503
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34239
        • GSK Investigational Site
      • Tampa, Florida, United States, 33613
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Austell, Georgia, United States, 30106
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Hines, Illinois, United States, 60141-5099
        • GSK Investigational Site
      • North Chicago, Illinois, United States, 60064
        • GSK Investigational Site
      • Peoria, Illinois, United States, 62526
        • GSK Investigational Site
      • Springfield, Illinois, United States, 62702
        • GSK Investigational Site
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46601
        • GSK Investigational Site
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • GSK Investigational Site
      • Waterloo, Iowa, United States, 50702
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • GSK Investigational Site
      • Covington, Louisiana, United States, 70433
        • GSK Investigational Site
      • Lafayette, Louisiana, United States, 70503
        • GSK Investigational Site
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
    • Maryland
      • Towson, Maryland, United States, 21286
        • GSK Investigational Site
    • Michigan
      • DeWitt, Michigan, United States, 48820
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Plainwell, Michigan, United States, 49080
        • GSK Investigational Site
      • Richland, Michigan, United States, 49083
        • GSK Investigational Site
      • Saint Joseph, Michigan, United States, 49085
        • GSK Investigational Site
    • Mississippi
      • Picayune, Mississippi, United States, 39466
        • GSK Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65211
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64108
        • GSK Investigational Site
      • Kirkwood, Missouri, United States, 63122
        • GSK Investigational Site
      • Saint Charles, Missouri, United States, 63301
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • GSK Investigational Site
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • GSK Investigational Site
      • Summit, New Jersey, United States, 07091
        • GSK Investigational Site
    • New York
      • Buffalo, New York, United States, 14215-1199
        • GSK Investigational Site
      • Great Neck, New York, United States, 11023
        • GSK Investigational Site
      • Kingston, New York, United States, 12401
        • GSK Investigational Site
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
      • New York, New York, United States, 10032
        • GSK Investigational Site
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43212
        • GSK Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
        • GSK Investigational Site
      • Allentown, Pennsylvania, United States, 19140
        • GSK Investigational Site
      • Audubon, Pennsylvania, United States, 19403
        • GSK Investigational Site
      • King of Prussia, Pennsylvania, United States, 19406
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • GSK Investigational Site
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406-7108
        • GSK Investigational Site
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
      • Summerville, South Carolina, United States, 29485
        • GSK Investigational Site
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • GSK Investigational Site
      • Morristown, Tennessee, United States, 37813
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23225
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis were included in the study

Description

Inclusion Criteria:

  • 15 pack-year smoking history.
  • Confirmed diagnosis of COPD.
  • Have two documented episodes of acute exacerbation in past 12 months.

Exclusion Criteria:

  • Clinical diagnosis of asthma.
  • Subjects not literate in the language of the questionnaire (e.g. US English).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Subjects with COPD
Subject has a confirmed clinical diagnosis of COPD, with or without chronic bronchitis.
Other: GSK questionnaire
GSK questionnaire will demonstrate the validity, reliability and responsiveness as a tool for measuring subject-reported outcomes during an acute exacerbation of chronic obstructive pulmonary disease.
Other: St. George's Respiratory Questionnaire
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health.
Other: Acute Short Form 12 version 2
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health
Other: Global Efficacy questionnaire
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline
Time Frame: Day 1
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject
Day 1
SGRQ Scores at exacerbation
Time Frame: Up to Day 14
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject
Up to Day 14
SGRQ Scores post-exacerbation
Time Frame: Up to Day 14
The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ sub-scores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the subject
Up to Day 14
Acute Short Form 12 version 2 (Acute SF-12v2) scores at Baseline
Time Frame: Day 1
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less.
Day 1
Acute SF-12v2 scores at exacerbation
Time Frame: Up to Day 14
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less.
Up to Day 14
Acute SF-12v2 scores post-exacerbation
Time Frame: Up to Day 14
The Acute SF-12v2 is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of health. It has been translated and validated in most major languages. The Acute SF-12v2 is self-administered by patients, and completed on average in 2 minutes or less.
Up to Day 14
Global Efficacy questionnaire scores at Baseline
Time Frame: Day 1
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Day 1
Global Efficacy questionnaire scores at exacerbation
Time Frame: Up to Day 14
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Up to Day 14
Global Efficacy questionnaire scores post-exacerbation
Time Frame: Up to Day 14
Global Efficacy questionnaire will be administered in an electronic form to validate test-retest reliability, responsiveness and minimum important difference (MID)
Up to Day 14
Physician reported measures at Baseline
Time Frame: Day 1
Day 1
Physician reported measures at exacerbation
Time Frame: Up to Day 14
Up to Day 14
Physician reported measures post-exacerbation
Time Frame: Up to Day 14
Up to Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in SGRQ-C Total and Subscales Scores
Time Frame: Up to Day 14
Up to Day 14
Percentage change in SGRQ-C scores
Time Frame: Up to Day 14
Up to Day 14
Change from Baseline in Acute SF-12v2 Total and Subscales Scores
Time Frame: Up to Day 14
Up to Day 14
Percentage change in Acute SF-12v2 scores
Time Frame: Up to Day 14
Up to Day 14
Change from Baseline in Global Efficacy Questionnaire Total and Subscales Scores
Time Frame: Up to Day 14
Up to Day 14
Percentage change in Global Efficacy Questionnaire scores
Time Frame: Up to Day 14
Up to Day 14
Change from Baseline in GSK questionnaire Total and Subscales Scores
Time Frame: Up to Day 14
Up to Day 14
Percentage change in GSK questionnaire scores
Time Frame: Up to Day 14
Up to Day 14
Time to resolution of each domain score
Time Frame: Up to Day 35
Up to Day 35
Time to resolution of total domain score
Time Frame: Up to Day 35
Up to Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 7, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2005

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPL104226

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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