- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00932737
(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
A Double-blind, Placebo-controlled, Randomized, Parallel-group Pilot Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used on Demand for the Treatment of Self-reported Functional Abdominal Pain Associated With Cramping
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Westlake Village, California, United States
- 202.839.01014 Boehringer Ingelheim Investigational Site
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Florida
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Hollywood, Florida, United States
- 202.839.01003 Boehringer Ingelheim Investigational Site
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Jupiter, Florida, United States
- 202.839.01001 Boehringer Ingelheim Investigational Site
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Jupiter, Florida, United States
- 202.839.01002 Boehringer Ingelheim Investigational Site
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Illinois
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Rockford, Illinois, United States
- 202.839.01017 Boehringer Ingelheim Investigational Site
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Indiana
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Indianapolis, Indiana, United States
- 202.839.01005 Boehringer Ingelheim Investigational Site
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Maryland
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Chevy Chase, Maryland, United States
- 202.839.01019 Boehringer Ingelheim Investigational Site
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Massachusetts
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Boston, Massachusetts, United States
- 202.839.01009 Boehringer Ingelheim Investigational Site
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New Hampshire
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Lebanon, New Hampshire, United States
- 202.839.01004 Boehringer Ingelheim Investigational Site
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New Jersey
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Toms River, New Jersey, United States
- 202.839.01011 Boehringer Ingelheim Investigational Site
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New York
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Lake Success, New York, United States
- 202.839.01008 Boehringer Ingelheim Investigational Site
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Ohio
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Cleveland, Ohio, United States
- 202.839.01015 Boehringer Ingelheim Investigational Site
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Oklahoma
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Norman, Oklahoma, United States
- 202.839.01021 Boehringer Ingelheim Investigational Site
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Oklahoma City, Oklahoma, United States
- 202.839.01010 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- 202.839.01013 Boehringer Ingelheim Investigational Site
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Texas
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San Antonio, Texas, United States
- 202.839.01006 Boehringer Ingelheim Investigational Site
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San Antonio, Texas, United States
- 202.839.01012 Boehringer Ingelheim Investigational Site
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Virginia
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Virginia Beach, Virginia, United States
- 202.839.01007 Boehringer Ingelheim Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States
- 202.839.01020 Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
History of recurrent abdominal pain with cramping (APC) for at least three months.
Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.
Exclusion Criteria:
Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode
Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode
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Active drug, one to five tablets per episode
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PLACEBO_COMPARATOR: Placebo
patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode
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1-5 tablets per episode
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1
Time Frame: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours
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The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
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At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours
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Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
Time Frame: At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.
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The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
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At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.
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Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
Time Frame: At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
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The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
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At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
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Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
Time Frame: At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
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The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
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At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
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Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1
Time Frame: At 4 hours after intake of first tablet of study medication in episode 1
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The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
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At 4 hours after intake of first tablet of study medication in episode 1
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Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
Time Frame: At 4 hours after intake of first tablet of study medication in episode 2
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The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
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At 4 hours after intake of first tablet of study medication in episode 2
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Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1
Time Frame: At 4 hours after intake of first tablet of study medication in episode 1
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At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
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At 4 hours after intake of first tablet of study medication in episode 1
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Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2
Time Frame: At 4 hours after intake of first tablet of study medication in episode 2
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At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
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At 4 hours after intake of first tablet of study medication in episode 2
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Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1
Time Frame: At 4 hours after intake of first tablet of study medication in episode 1
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At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?"
based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
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At 4 hours after intake of first tablet of study medication in episode 1
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Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2
Time Frame: At 4 hours after intake of first tablet of study medication in episode 2
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At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?"
based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
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At 4 hours after intake of first tablet of study medication in episode 2
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Time to Relief in Episode 1
Time Frame: From intake of first tablet of study medication up to 4 hours thereafter in episode 1
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Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1.
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From intake of first tablet of study medication up to 4 hours thereafter in episode 1
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Time to Relief in Episode 2
Time Frame: From intake of first tablet of study medication up to 4 hours thereafter in episode 2
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Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.
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From intake of first tablet of study medication up to 4 hours thereafter in episode 2
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Number of Tablets of Study Medication Taken
Time Frame: From intake of first tablet of study medication up to 4 hours thereafter in each episode.
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Number of tablets of study medication taken in each of the two episode.
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From intake of first tablet of study medication up to 4 hours thereafter in each episode.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients With Drug-related Adverse Events
Time Frame: From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.
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From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.
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Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1
Time Frame: At 4 hours after intake of first tablet of study medication in episode 1
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Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?"
("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied").
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At 4 hours after intake of first tablet of study medication in episode 1
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Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2
Time Frame: At 4 hours after intake of first tablet of study medication in episode 2
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Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?"
("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied")
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At 4 hours after intake of first tablet of study medication in episode 2
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Change From Baseline to End of Study Visit in Systolic Blood Pressure
Time Frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
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Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure.
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At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
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Change From Baseline to End of Study Visit in Diastolic Blood Pressure
Time Frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure.
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At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change From Baseline to End of Study Visit in Pulse Rate
Time Frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate.
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At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change From Baseline to End of Study Visit in Body Temperature
Time Frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature.
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At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change From Baseline to End of Study Visit in Respiratory Rate
Time Frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate.
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At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202.839
- U09-3181-01
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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