ColicPhase 2NCT02242292
Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort
A Phase 2 study testing Hyoscine butylbromide in people with Colic, run by Boehringer Ingelheim.
Trial summary
Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with cramping when used as needed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colic
- What is being tested?
- Hyoscine butylbromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 527 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jan 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females 18 years of age and older
- Have at least a 3-month self-reported history of recurrent episodic symptoms, usually lasting for 1 hour or more, of self-described abdominal pain or discomfort associated with cramping, which they routinely either have not treated or treated using Over-the-counter (OTC) medications, in which subjects suffered these symptoms at a frequency of at least twice monthly to several times weekly, but not on a daily basis. The episodes of abdominal pain or discomfort may have been associated with other symptoms of GI dysfunction, such as diarrhea, constipation, and bloating
- Symptoms typically have a moderate or greater severity (moderate, severe, very severe) and are sufficiently bothersome to require treatment or intervention
- Symptoms are not associated with abdominal tenderness, swelling, fever, weight loss, or passage of blood per rectum. The onset of symptoms may or may not have been associated with ingestion of food or beverages
- The episodes of abdominal pain or discomfort may have been associated with other symptoms of GI dysfunction, such as diarrhea, cramping, constipation, and bloating
- Subjects are required to be able to comprehend and participate in the activities required for participation in the trial, to have the ability to attend required site visits, and to be available and have the facility to participate in a daily telephone call or computer entry (using a touch-tone phone or computer IVRS entry), which served as the mechanism for diary entry, during the 6-week course of the study. Subjects were required to successfully complete an Interactive voice response system (IVRS) training session prior to entry into the study
- All subjects completed and signed an informed consent form
Who cannot join
- Subjects who reported having these symptoms for the first time, particularly if they were 50 years or older, as this may have been a sign of a more serious organic disease
- Subjects with a known hypersensitivity or allergy to hyoscine butylbromide or any of the inactive ingredients
- Subjects who are currently under a physician's care for abdominal symptoms and/or not using medication or using prescription or OTC medications prescribed by a physician to treat symptoms of abdominal pain, cramping and discomfort or taking prescription medication(s) for the treatment of Irritable bowel syndrome (IBS) (Bentyl® or other antispasmodics, Zelnorm® [tegaserod], Lotronex® [alosetron], prokinetic agents). Current physician's care was defined as the subject presently following clinician advice regarding treatment and management of the abdominal pain or discomfort associated with the cramping symptom
- Subjects who are having symptoms of abdominal swelling, fever associated with symptoms of abdominal pain or discomfort associated with cramping, and/or experiencing passage of blood per rectum associated with symptoms of abdominal pain or discomfort associated with cramping, or who have any evidence of abdominal tenderness (or any other evidence of an acute abdomen), abdominal masses, organomegaly or any other abnormality on abdominal examination
- Subjects with a history of colon or other GI cancer or malignancy, inflammatory bowel disease, or Crohn's disease
- Subjects with chronic constipation
Show all 18Show fewer
- Subjects with myasthenia gravis or megacolon
- Subjects who have undergone abdominal surgery within the past 2 years, having GI surgery resulting in removal of all or part of the colon, small intestine, or stomach, or having a history of GI by-pass surgery for weight reduction
- Prior history of gallbladder removal, appendectomy, and/or surgery for peptic ulcer disease or gastroesophageal reflux disease (GERD), was not exclusionary.
- Subjects whose major symptoms were retrosternal burning, acid reflux, acid regurgitation, or heartburn are excluded
- Subjects using prescription anticholinergic medications or medications for the treatment of myasthenia gravis, glaucoma, or ocular hypertension are excluded
- Subjects who were currently participating in other trials or who participated in a clinical trial within the prior 30 days are excluded
- Women who reported being pregnant, are nursing, or who are of child-bearing potential and not using an adequate method of birth control (medication, device, abstinence, sterilization for either partner) for 30 days before enrollment and did not agree to continue using an adequate method of birth control for 30 days after completion of the trial are excluded
- Any women of childbearing potential who have a positive serum pregnancy test are excluded
- Post-menopausal women who have been post-menopausal for a duration of less than 2 years and did not have a hysterectomy or tubal ligation procedure are excluded
- Subjects who have tachyarrhythmia (defined as any disturbance of the heart's rhythm, regular or irregular, resulting in a rate over 100 beats per minute) during a physical examination are excluded
- Subjects who have been previously diagnosed with benign prostatic hyperplasia (BPH) or subjects who experienced urinary retention are excluded
- Subjects with clinically significant cardiovascular disease in the opinion of the investigator (including hypotension, hypertension, severe coronary artery disease, congestive heart failure, angina pectoris) are excluded
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Parallel Group Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used On-demand up to 7 Episodes Over a Period of 6 Weeks for the Treatment of Occasional Episodes of Self-reported Abdominal Pain, Cramping, and Discomfort Associated With Cramping in an OTC-like Study Population
Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with cramping when used as needed
- Conditions
- Colic
- Being tested
- Hyoscine butylbromide, Placebo
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine butylbromideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine butylbromide | Experimental | 5 tablets taken in a 24-hour period/each episode:
* for up to 7 episodes, or
* over a period of up to 6 weeks Receives: Drug: Hyoscine butylbromide |
| 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.
Response rate in treating the first episode of abdominal pain or discomfort associated with cramping
(Response was defined as achieving adequate relief of symptoms, as measured on a subject's diary using a dichotomized response to the question)
Measured: within 24 hours after starting treatment
Secondary outcomes (17)
Response rate to trial medication
responders were those who obtained adequate relief for 50% or more of all treated episodes
Measured: up to day 41
Assessment of Average symptom relief rated on 4-point scale
based on the "Symptom Relief Index''
Measured: up to day 41
Time to onset of any effect after the first tablet taken assessed on 5-point scale
Measured: within 24 hours after starting treatment
Time to onset of any effect assessed on 5-point scale
Measured: up to day 41
Time to obtain adequate relief after the first tablet taken assessed on 5-point scale
Measured: within 24 hours after starting treatment
Time to obtain adequate relief assessed on 5-point scale
Measured: up to day 41
Average time to obtain adequate relief per subject assessed on 5-point scale
Measured: up to day 41
Average number of tablets taken to treat episodes per subject
measured for each treated episode by the subject's response to the question on the number of tablets taken for each treated episode or 24-hour period
Measured: up to day 41
Percentage of episodes of diarrhea
Measured: up to day 41
Percentage of bloating episodes
Measured: up to day 41
Percentage of constipation episodes
Measured: up to day 41
Percentage of episodes in relief of abdominal pain or discomfort associated with cramping
Measured: up to day 41
Global Assessment of efficacy by subject on 4-point scale
Measured: Day 42
Global Assessment of tolerability by subject on a 4-point scale
Measured: Day 42
Global assessment of tolerability by investigator on a 4- point scale
Measured: Day 42
Number of patients with adverse events
Measured: up to 42 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startApr 2006
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColicStudies 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
- 527 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
- NCT02242292
- Sponsor's protocol ID
- 202.832
- Status last verified
- Dec 2017
- First submitted
- 16 Sep 2014
- Last updated
- 28 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Parallel Group Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used On-demand up to 7 Episodes Over a Period of 6 Weeks for the Treatment of Occasional Episodes of Self-reported Abdominal Pain, Cramping, and Discomfort Associated With Cramping in an OTC-like Study Population
- ClinicalTrials.gov ID
- NCT02242292
- Acronym / sponsor ID
- 202.832
- Conditions
- Colic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jan 2007 (actual)
- First posted
- 17 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 determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with cramping when used as needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoscine butylbromide | Experimental | Drug: Hyoscine butylbromide5 tablets taken in a 24-hour period/each episode: * for up to 7 episodes, or * over a period of up to 6 weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult males and females 18 years of age and older
- Have at least a 3-month self-reported history of recurrent episodic symptoms, usually lasting for 1 hour or more, of self-described abdominal pain or discomfort associated with cramping, which they routinely either have not treated or treated using Over-the-counter (OTC) medications, in which subjects suffered these symptoms at a frequency of at least twice monthly to several times weekly, but not on a daily basis. The episodes of abdominal pain or discomfort may have been associated with other symptoms of GI dysfunction, such as diarrhea, constipation, and bloating
- Symptoms typically have a moderate or greater severity (moderate, severe, very severe) and are sufficiently bothersome to require treatment or intervention
- Symptoms are not associated with abdominal tenderness, swelling, fever, weight loss, or passage of blood per rectum. The onset of symptoms may or may not have been associated with ingestion of food or beverages
- The episodes of abdominal pain or discomfort may have been associated with other symptoms of GI dysfunction, such as diarrhea, cramping, constipation, and bloating
Key exclusion criteria (18 listed)
- Subjects who reported having these symptoms for the first time, particularly if they were 50 years or older, as this may have been a sign of a more serious organic disease
- Subjects with a known hypersensitivity or allergy to hyoscine butylbromide or any of the inactive ingredients
- Subjects who are currently under a physician's care for abdominal symptoms and/or not using medication or using prescription or OTC medications prescribed by a physician to treat symptoms of abdominal pain, cramping and discomfort or taking prescription medication(s) for the treatment of Irritable bowel syndrome (IBS) (Bentyl® or other antispasmodics, Zelnorm® [tegaserod], Lotronex® [alosetron], prokinetic agents). Current physician's care was defined as the subject presently following clinician advice regarding treatment and management of the abdominal pain or discomfort associated with the cramping symptom
- Subjects who are having symptoms of abdominal swelling, fever associated with symptoms of abdominal pain or discomfort associated with cramping, and/or experiencing passage of blood per rectum associated with symptoms of abdominal pain or discomfort associated with cramping, or who have any evidence of abdominal tenderness (or any other evidence of an acute abdomen), abdominal masses, organomegaly or any other abnormality on abdominal examination
- Subjects with a history of colon or other GI cancer or malignancy, inflammatory bowel disease, or Crohn's disease
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 |
|---|---|---|
| Hyoscine butylbromide | Drug | Hyoscine butylbromide |
| Placebo | Drug | Placebo |
Primary outcome
Response rate in treating the first episode of abdominal pain or discomfort associated with cramping
Time frame: within 24 hours after starting treatment
(Response was defined as achieving adequate relief of symptoms, as measured on a subject's diary using a dichotomized response to the question)
17 secondary outcomes
Response rate to trial medication
Time frame: up to day 41
Assessment of Average symptom relief rated on 4-point scale
Time frame: up to day 41
Time to onset of any effect after the first tablet taken assessed on 5-point scale
Time frame: within 24 hours after starting treatment
Time to onset of any effect assessed on 5-point scale
Time frame: up to day 41
Time to obtain adequate relief after the first tablet taken assessed on 5-point scale
Time frame: within 24 hours after starting treatment
Time to obtain adequate relief assessed on 5-point scale
Time frame: up to day 41
Average time to obtain adequate relief per subject assessed on 5-point scale
Time frame: up to day 41
Average number of tablets taken to treat episodes per subject
Time frame: up to day 41
Percentage of episodes of diarrhea
Time frame: up to day 41
Percentage of bloating episodes
Time frame: up to day 41
Percentage of constipation episodes
Time frame: up to day 41
Percentage of episodes in relief of abdominal pain or discomfort associated with cramping
Time frame: up to day 41
Global Assessment of efficacy by subject on 4-point scale
Time frame: Day 42
Global Assessment of tolerability by subject on a 4-point scale
Time frame: Day 42
Global assessment of tolerability by investigator on a 4- point scale
Time frame: Day 42
Number of patients with adverse events
Time frame: up to 42 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 42 days
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 28 Dec 2017.
- Related InfoLink provided by the sponsor.
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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 Hyoscine butylbromide in people with Colic, 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 7 inclusion and 18 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 28 Dec 2017. 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?
Response rate in treating the first episode of abdominal pain or discomfort associated with cramping (time frame: within 24 hours after starting treatment). 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 28 Dec 2017.