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Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima

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ClinicalTrials.gov Identifier: NCT02910167
Recruitment Status : Completed
First Posted : September 21, 2016
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.

Condition or disease Intervention/treatment
Acute Pain Dysmenorrhea Drug: Hyoscine n-butylbromide Drug: Paracetamol

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Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima
Actual Study Start Date : October 15, 2016
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : February 20, 2017

Group/Cohort Intervention/treatment
Men with spasmodic syndromes
Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Drug: Hyoscine n-butylbromide
Hyoscine n-butylbromide 10 mg

Drug: Paracetamol
Paracetamol 500 mg

Women with spasmodic syndromes
Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Drug: Hyoscine n-butylbromide
Hyoscine n-butylbromide 10 mg

Drug: Paracetamol
Paracetamol 500 mg




Primary Outcome Measures :
  1. Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients [ Time Frame: From the initial dose of study drug until end of the follow up period, up to 113 days ]
    Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.


Secondary Outcome Measures :
  1. Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. [ Time Frame: From the initial dose of study drug until end of the follow up period, up to 113 days ]
    Percentage of patients with different transaminase levels found by the doctor during the clinical evaluation of patients with symptoms related to potential liver damage. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.

  2. Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima [ Time Frame: From the initial dose of study drug until end of the follow up period, up to 113 days ]
    Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.

  3. Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment [ Time Frame: From the initial dose of study drug until end of the follow up period, up to 113 days ]
    Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.

  4. Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N [ Time Frame: From the initial dose of study drug until end of the follow up period, up to 113 days ]
    Percentage of patients with different variables related to the occurrence of increase of transaminases in patients under treatment with Buscapina Compositum N in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Metropolitan Lima
Criteria

Inclusion criteria:

  1. Patients 18 years of age and older who have received at least one dose of BUSCAPINA COMPOSITUM N according to label indications and who attend to one of the pharmacies, clinics, or private doctors office selected for the study.
  2. Patients who agree to adhere to the protocol procedures of this study.
  3. Women who are not pregnant or breast feeding
  4. Persons who sign the informed consent

Exclusion criteria:

  1. Patients with allergy to BUSCAPINA COMPOSITUM N or any of the compounds in the formula.
  2. Patients with mechanical stenosis of the gastrointestinal tract.
  3. Patients with myasthenia gravis.
  4. Patients with megacolon.
  5. Patients breastfeeding at the time of enrollment or who have become pregnant during treatment with BUSCAPINA COMPOSITUM N.
  6. Patients with clinical evidence of immunosuppression.
  7. Patients with urinary retention subvesical obstruction (such as prostatic adenoma).
  8. Patients with right-angle glaucoma.
  9. Patients with tachycardia and tachyarrhythmia.
  10. Patients with severe hepatic impairment.
  11. Patients with psychiatric disorders.
  12. Patients with alcohol dependence or drugs.
  13. Patients who discontinue the protocol are not eligible for re-enrollment.
  14. Researchers, company personnel or their relatives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910167


Locations
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Peru
Multiple Locations, Peru
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02910167     History of Changes
Other Study ID Numbers: 218.705
First Posted: September 21, 2016    Key Record Dates
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Acute Pain
Dysmenorrhea
Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Acetaminophen
Scopolamine
Butylscopolammonium Bromide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics