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Completed

NCT Number: NCT00932737

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

202.839.01014 Boehringer Ingelheim Investigational Site, Westlake Village, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

Placebo

Drug

1-5 tablets per episode

HBB 20 mg

Drug

Active drug, one to five tablets per episode

Primary outcomes

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

    Time frame: 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

    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).

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

    Time frame: 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.

    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).

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

    Time frame: 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.

    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).

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

    Time frame: 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.

    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).

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

    Time frame: At 4 hours after intake of first tablet of study medication 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.

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

    Time frame: At 4 hours after intake of first tablet of study medication 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.

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

    Time frame: At 4 hours after intake of first tablet of study medication 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".

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

    Time frame: At 4 hours after intake of first tablet of study medication 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".

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

    Time frame: At 4 hours after intake of first tablet of study medication 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".

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

    Time frame: At 4 hours after intake of first tablet of study medication 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".

  11. Time to Relief in Episode 1

    Time frame: From intake of first tablet of study medication up to 4 hours thereafter 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.

  12. Time to Relief in Episode 2

    Time frame: From intake of first tablet of study medication up to 4 hours thereafter 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.

  13. Number of Tablets of Study Medication Taken

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

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

Secondary outcomes

  1. Percentage of Patients With Drug-related Adverse Events

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

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

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

    Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?" ("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied").

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

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

    Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?" ("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied")

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

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

    Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure.

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

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

    Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure.

  6. Change From Baseline to End of Study Visit in Pulse Rate

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

    Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate.

  7. Change From Baseline to End of Study Visit in Body Temperature

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

    Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature.

  8. Change From Baseline to End of Study Visit in Respiratory Rate

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

    Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Parallel-group Pilot Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used on Demand for the Treatment of Self-reported Functional Abdominal Pain Associated With Cramping

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 3, 2009
Registry last updated
May 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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