An observational study in Acute Pain and Dysmenorrhea, sponsored by Boehringer Ingelheim. Completed at 1 site in Peru. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Boehringer Ingelheim · Observational
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 360 is above the median of 150 across 113 observational studies indexed under Acute Pain.
Browse Acute Pain studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
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Metropolitan Lima
Exclusion criteria:
Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Drug: Hyoscine n-butylbromide · Drug: Paracetamol
Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
Drug: Hyoscine n-butylbromide · Drug: Paracetamol
Hyoscine n-butylbromide 10 mg
Paracetamol 500 mg
Hyoscine n-butylbromide 10 mg
Paracetamol 500 mg
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.
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.
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.
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
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 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.
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
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.
Time frame: From the initial dose of study drug until end of the follow up period, up to 113 days
Observational prospective study to evaluate adverse events (AEs), Risk factors and drug utilization of Buscapina Compositum N in adults from metropolitan lima
| Milestone | Buscapina Compositum N |
|---|---|
| Started | 360 |
| Completed | 341 |
| Not completed | 19 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 18 |
Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.
| Percentage of Patients | Buscapina Compositum N |
|---|---|
| Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients | 0.0 |
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.
| Percentage of Patients | Buscapina Compositum N |
|---|---|
| Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage. | NA |
Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.
| Percentage of Patients | Buscapina Compositum N |
|---|---|
| Patient took the medication with liquids (Yes) | 100.0 |
| Patient took the medication with liquids (No) | 0.0 |
| Type of liquid used (Water) | 94.7 |
| Type of liquid used (Juice) | 8 |
| Type of liquid used (Other) | 2.9 |
| Amount of liquid used (A straw/sip) | 0.3 |
| Amount of liquid used (1/4 cup) | 3.8 |
| Amount of liquid used (1/2 cup) | 33.0 |
| Amount of liquid used (A full cup) | 44.7 |
| Amount of liquid used (More than a cup) | 18.1 |
| Storage of medicine (In a dry and fresh location) | 98.0 |
| Storage of medicine (In a hot location) | 0.3 |
| Storage of medicine (In the refrigerator) | 0.0 |
| Storage of medicine (Other) | 1.8 |
| Reason - Not taking medicine (No symptoms anymore) | 51.4 |
| Reason - Not taking medicine (Forgot it) | 23.4 |
| Reason - Not taking medicine (Had no time) | 5.6 |
| Reason - Not taking medicine (Other) | 12.2 |
| Reason - Not taking medicine (No answer) | 7.5 |
Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.
| Percentage of Patients | Buscapina Compositum N |
|---|---|
| Abdominal pain (upper) | 0.3 |
| Diarrhoea | 0.3 |
| Nausea | 0.3 |
| Constipation | 0.3 |
| Abdominal Pain | 0.3 |
| Dizziness | 0.3 |
| Somnolence | 1.2 |
| Cough | 0.3 |
| Urine color abnormal | 0.3 |
| Headache + nausea | 0.3 |
| Nausea + constipation | 0.3 |
| Flatulence + constipation | 0.3 |
| Polydipsia + abdominal pain (upper) | 0.3 |
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.
| Percentage of Patients | 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 | NA |
Collected over From the initial dose of study drug until end of the follow up period, up to 113 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buscapina Compositum N | 0/360 (0%) | 0/360 (0%) | 0/360 (0%) |
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.
| Age, Continuous(Years) | Buscapina Compositum N |
|---|---|
| Mean | 36.2 ± 13.6 |
| Sex: Female, Male(Participants) | Buscapina Compositum N |
|---|---|
| Female | 270 |
| Male | 90 |
| Race and Ethnicity Not Collected(Participants) | Buscapina Compositum N |
|---|
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Boehringer Ingelheim