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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men with spasmodic syndromes | Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes |
| |
| Women with spasmodic syndromes | Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyoscine n-butylbromide | Drug | Hyoscine n-butylbromide 10 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients | Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients. | From the initial dose of study drug until end of the follow up period, up to 113 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. | 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. |
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Inclusion criteria:
Exclusion criteria:
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Metropolitan Lima
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Peru |
All patients were screened for eligibility to participate in the trial. Patients attended one of 4 specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.
Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima
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| ID | Title | Description |
|---|---|---|
| FG000 | Buscapina Compositum N | Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2017 |
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| Paracetamol |
| Drug |
Paracetamol 500 mg |
|
| Hyoscine n-butylbromide | Drug | Hyoscine n-butylbromide 10 mg |
|
| Paracetamol | Drug | Paracetamol 500 mg |
|
| 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 | Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima. | 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 | Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N. | 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 | 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. | From the initial dose of study drug until end of the follow up period, up to 113 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients who have received at least one dose of Buscapina Compositum N according to label indications and who attended to one of the health centers selected for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Buscapina Compositum N | Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of signing informed consent form is presented. | Patients who have received at least one dose of Buscapina Compositum N according to label indications and who attended to one of the health centers selected for the study. | Mean | Standard Deviation | Years |
| |||||||||||||
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | Patients who have received at least one dose of Buscapina Compositum N according to label indications and who attended to one of the health centers selected for the study. | Count of Participants | Participants |
| ||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients | Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients. | Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit. | Posted | Number | Percentage of Patients | From the initial dose of study drug until end of the follow up period, up to 113 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. | 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. | Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit, and who reported symptoms related to potential liver damage at the follow-up visit. | Posted | Number | Percentage of Patients | From the initial dose of study drug until end of the follow up period, up to 113 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima | Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima. | Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit. | Posted | Number | Percentage of Patients | From the initial dose of study drug until end of the follow up period, up to 113 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment | Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N. | Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit, and who developed any adverse event during treatment. | Posted | Number | Percentage of Patients | From the initial dose of study drug until end of the follow up period, up to 113 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N | 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. | Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit. | Posted | Number | Percentage of Patients | From the initial dose of study drug until end of the follow up period, up to 113 days |
|
|
From the initial dose of study drug until end of the follow up period, up to 113 days
During the observational period, all adverse events following exposure to Buscapina Compositum N were recorded in the case report form, regardless of seriousness or causality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buscapina Compositum N | Combination of 10 milligram (mg) of hyoscine n-butylbromide (HBB) and 500 mg of paracetamol. The dose of Buscapina Compositum N was according to label instructions which patients had to acquire on their own (one to two tablets by mouth every 8 hours for 3 to 4 days, swallowed whole with sufficient water). | 0 | 360 | 0 | 360 | 0 | 360 |
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Since the study is conducted at some health centers, it cannot be generalized to the whole population who uses study drug. It is without a control group, thus not able to compare cumulative incidence of AE with the patients not exposed to this drug
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Mar 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
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| Male |
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