Gastrointestinal DiseasesPhase 2NCT02229786
Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
A Phase 2 study testing Buscopan® plus, Buscopan® and Paracetamol in people with Gastrointestinal Diseases, run by Boehringer Ingelheim.
Trial summary
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Buscopan® plus, Buscopan® and Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,637 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Oct 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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 to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Buscopan® plus, Buscopan®, Paracetamol, Placebo
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buscopan® plusDrug
Buscopan®Drug
ParacetamolDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Buscopan® plus | Experimental | Not described Receives: Drug: Buscopan® plus |
| Buscopan® | Active comparator | Not described Receives: Drug: Buscopan® |
| Paracetamol | Active comparator | Not described Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean decrease in pain intensity on a VAS (visual analog scale)
Measured: 3 weeks
Secondary outcomes (4)
Frequency of pain on a 4-stage verbal rating scale
Measured: up to 4 weeks
Global assessment of efficacy by patient on a 5-point rating scale
Measured: up to 4 weeks
Global assessment of efficacy by investigator on a 5-point rating scale
Measured: up to 4 weeks
Number of patients with adverse events
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startFeb 1998
- Primary completionOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229786
- Sponsor's protocol ID
- 218.202
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02229786
- Acronym / sponsor ID
- 218.202
- Conditions
- Gastrointestinal Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,637 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1998
- Primary completion
- Oct 1999 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buscopan® plus | Experimental | Drug: Buscopan® plus |
| Buscopan® | Active comparator | Drug: Buscopan® |
| Paracetamol | Active comparator | Drug: Paracetamol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buscopan® plus | Drug | Buscopan® plus |
| Buscopan® | Drug | Buscopan® |
| Paracetamol | Drug | Paracetamol |
| Placebo | Drug | Placebo |
Primary outcome
Mean decrease in pain intensity on a VAS (visual analog scale)
Time frame: 3 weeks
4 secondary outcomes
Frequency of pain on a 4-stage verbal rating scale
Time frame: up to 4 weeks
Global assessment of efficacy by patient on a 5-point rating scale
Time frame: up to 4 weeks
Global assessment of efficacy by investigator on a 5-point rating scale
Time frame: up to 4 weeks
Number of patients with adverse events
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buscopan® plus, Buscopan® and Paracetamol in people with Gastrointestinal Diseases, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean decrease in pain intensity on a VAS (visual analog scale) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.