Hyoscine butylbromide

Generic Name: Hyoscine butylbromide

Brand Names: Buscopan

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₃₀NO_₄

CAS Number: 7182-53-8

Unique Ingredient Identifier: 2Z3E1OF81V

Background: Butylscopolamine is a peripherally acting antimuscarinic, anticholinergic agent. It is used to treat pain and discomfort caused by abdominal cramps, menstrual cramps, or other spasmodic activity in the digestive system. It is also effective at preventing bladder spasms. It is not a pain medication in the normal sense, since it does not directly affect pain, but rather works to prevent painful cramps and spasms from occurring. It is on the WHO Model List of Essential Medicines, the most important medications needed in a basic health system.

Indication: Used to treat abdmoninal cramping and pain .

Associated Conditions: Gastrointestinal spastic and hypermotility disorders, Infantile Hypertrophic Pyloric Stenosis, Menstrual Distress (Dysmenorrhea), Muscle Spasms, Pain, Primary Dysmenorrhoea, Stiffness of the Urinary Tract, Acute biliary spasm, Acute gastrointestinal spasms, Acute genitourinary spasms, Genitourinary smooth muscle spasm

Associated Therapies: Analgesia, Smooth muscle relaxation prior to radiological procedures therapy

Clinical Trials

Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: hyoscine butylbromide

First Posted Date: 2015-08-05

Last Posted Date: 2017-04-05

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 56

Registration Number: NCT02516098

Locations: 🇨🇦
Boehringer Ingelheim Investigational Site, Bloemfontein, Canada

Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Hyoscine butylbromide

First Posted Date: 2014-10-10

Last Posted Date: 2014-10-10

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 60

Registration Number: NCT02261077

Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort

Phase 2

Completed

Conditions: Colic

Interventions: Drug: Hyoscine butylbromide
Drug: Placebo

First Posted Date: 2014-09-17

Last Posted Date: 2017-12-28

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 527

Registration Number: NCT02242292

Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms

Phase 2

Completed

Conditions: Gastrointestinal Diseases

Interventions: Drug: Placebo
Drug: Buscopan®
Drug: Paracetamol
Drug: Buscopan® plus

First Posted Date: 2014-09-01

Last Posted Date: 2014-09-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 1637

Registration Number: NCT02229786

Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain

Phase 3

Completed

Conditions: Intestinal Diseases

Interventions: Drug: Buscopan® (hyoscine butylbromide)
Drug: 654-II (anisodamine)

First Posted Date: 2013-08-27

Last Posted Date: 2016-03-08

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 299

Registration Number: NCT01929044

Locations: 🇨🇳
202.848.86013 Boehringer Ingelheim Investigational Site, Beijing, China
🇨🇳
202.848.86020 Boehringer Ingelheim Investigational Site, Changsha, China
🇨🇳
202.848.86007 Boehringer Ingelheim Investigational Site, Chongqing, China

and more 17 locations