Clinical trial NCT02229786: Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
Official title: Buscopan® Plus, Buscopan®, Paracetamol and Placebo: Double-blind Randomized Group Comparison to Investigate the Efficacy and Tolerability of the Film-coated Tablets in Patients With Painful Gastric or Intestinal Spasms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Diseases
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-01
Enrollment: 1637
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.


Eligibility criteria: Inclusion Criteria:

* Male and female patients
* Age: 18 - 70 years
* Diagnosis: recurring painful gastric or intestinal spasms such as occur e.g. in irritable bowel syndrome, which are not organic in origin, have been present for at least 2 months, and are serious enough to interfere with everyday activities
* Patient briefing as per §§ 40/41 of the Arzneimittelgesetz (AMG) and patient's declaration of Informed Consent in writing, in agreement with Good Clinical Practice (GCP) and current legal requirements
* A pain assessment of 3 cm or more on the visual analog scale on at least one of the 2 days immediately preceding the second visit

Exclusion Criteria:

* Painful gastric or intestinal spasms of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance
* Tumour pain/malignant growths
* Patients with other severe pain states of organic origin (e.g. biliary colic)
* Mechanical stenoses of the gastrointestinal tract, megacolon
* Urinary retention associated with mechanical stenoses of the urinary tract (e.g. in prostate adenoma)
* Narrow-angle glaucoma
* Tachyarrhythmia
* Myasthenia gravis
* Glucose 6-phosphate dehydrogenase deficiency (danger of haemolytic anaemia)
* Known hypersensitivity to N-butylscopolammonium bromide or paracetamol
* Severe liver impairment (e.g. through chronic alcohol abuse, hepatitis):

  * a) Serum-Glutamate-Oxalacetat-Transaminase/ Aspartate Aminotransferase (SGOT) higher than four times the norm
  * b) Bilirubin \> 3 mg/dl
  * c) Quick's value \< 70%
* Meulengracht-Gilbert syndrome (metabolic disturbance with episodes of jaundice)
* Severe kidney failure: creatinine \> 2 mg/dl
* Known depression or known mental illness, anxiety disturbance
* Concomitant intake of analgesics, nonsteroidal antiinflammatory drugs (NSAIDs) and/or spasmolytics, anticholinergics, nitrates
* Concomitant medication affecting gastrointestinal motility
* Regular (daily) use of laxatives
* Drugs that induce liver enzymes
* Concomitant administration of chloramphenicol
* Use of narcotics
* Antidepressant treatment or treatment with psychoactive drugs
* Pregnancy and lactation
* Alcohol abuse (more than 60 g alcohol/day)
* Frequent vomiting that might prevent adequate absorption of the active ingredient after the film-coated tablet is taken
* Patients who are unlikely to be able to keep the examination appointments or cannot reliably take the study medication regularly
* Simultaneous participation in another clinical study
* Patients who are not trained in the VAS (PI) at Visit 1

Primary outcomes:
measure: Mean decrease in pain intensity on a VAS (visual analog scale)
timeFrame: 3 weeks
Secondary outcomes:
measure: Frequency of pain on a 4-stage verbal rating scale
timeFrame: up to 4 weeks
measure: Global assessment of efficacy by patient on a 5-point rating scale
timeFrame: up to 4 weeks
measure: Global assessment of efficacy by investigator on a 5-point rating scale
timeFrame: up to 4 weeks
measure: Number of patients with adverse events
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References: