(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis

NCT00932737 | Completed Phase 2 Results

• 2 other identifiers: 202.839U09-3181-01
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 19

Brief Summary

The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (13)

• Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1

  The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).

  At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours

• Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2

  The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).

  At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.

• Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1

  The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).

  At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.

• Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2

  The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).

  At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.

• Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1

  The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.

  At 4 hours after intake of first tablet of study medication in episode 1

• Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2

  The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.

  At 4 hours after intake of first tablet of study medication in episode 2

• Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1

  At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".

  At 4 hours after intake of first tablet of study medication in episode 1

• Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2

  At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".

  At 4 hours after intake of first tablet of study medication in episode 2

• Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1

  At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".

  At 4 hours after intake of first tablet of study medication in episode 1

• Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2

  At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".

  At 4 hours after intake of first tablet of study medication in episode 2

• Time to Relief in Episode 1

  Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1.

  From intake of first tablet of study medication up to 4 hours thereafter in episode 1

• Time to Relief in Episode 2

  Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.

  From intake of first tablet of study medication up to 4 hours thereafter in episode 2

• Number of Tablets of Study Medication Taken

  Number of tablets of study medication taken in each of the two episode.

  From intake of first tablet of study medication up to 4 hours thereafter in each episode.

Secondary Outcomes (8)

• Percentage of Patients With Drug-related Adverse Events

  From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.

• Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1

  At 4 hours after intake of first tablet of study medication in episode 1

• Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2

  At 4 hours after intake of first tablet of study medication in episode 2

• Change From Baseline to End of Study Visit in Systolic Blood Pressure

  At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)

• Change From Baseline to End of Study Visit in Diastolic Blood Pressure

  At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Study Arms (2)

Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode

ACTIVE COMPARATOR

Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode

Drug: HBB 20 mg

Placebo

PLACEBO COMPARATOR

patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode

Drug: Placebo

Interventions

Placebo DRUG

1-5 tablets per episode

Placebo

HBB 20 mg DRUG

Active drug, one to five tablets per episode

Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of recurrent abdominal pain with cramping (APC) for at least three months.
• Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.

You may not qualify if:

• Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (19)

202.839.01014 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

202.839.01003 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

202.839.01001 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Location

202.839.01002 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Location

202.839.01017 Boehringer Ingelheim Investigational Site

Rockford, Illinois, United States

Location

202.839.01005 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

202.839.01019 Boehringer Ingelheim Investigational Site

Chevy Chase, Maryland, United States

Location

202.839.01009 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

202.839.01004 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

202.839.01011 Boehringer Ingelheim Investigational Site

Toms River, New Jersey, United States

Location

202.839.01008 Boehringer Ingelheim Investigational Site

Lake Success, New York, United States

Location

202.839.01015 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

202.839.01021 Boehringer Ingelheim Investigational Site

Norman, Oklahoma, United States

Location

202.839.01010 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

202.839.01013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

202.839.01006 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

202.839.01012 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

202.839.01007 Boehringer Ingelheim Investigational Site

Virginia Beach, Virginia, United States

Location

202.839.01020 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Abdominal Pain

Interventions

beta-Globins

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Hemoglobin Subunits; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: July 3, 2009
• Study Start: June 9, 2009
• Primary Completion: February 8, 2010
• Study Completion: February 8, 2010
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-04

Locations

US (19)