Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort

The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from no pain to the most severe pain imaginable).

Time frame: 3 days (1 day)

Population: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.

The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: How many times have the spasm-like pains occurred today? 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.

Time frame: Up to 3 days.

Population: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.

The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).

Time frame: Post 3 days of treatment.

Population: Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.

The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).

Time frame: Day 3.

Population: Safety Set (SFS): All randomized subjects who took at least one dose of study medication.

The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.

Time frame: Up to 3 days.

Population: Safety Set (SFS): All randomized subjects who took at least one dose of study medication.

Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).

Time frame: Up to 3 days.

Population: Safety Set (SFS): All randomized subjects who took at least one dose of study medication.

This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.

Time frame: From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.

Population: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.