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临床试验/NCT00526097
NCT00526097已完成3 期

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks Treatment With Bisacodyl (Dulcolax) Tablets 10mg Administered Orally, Once Daily, in Patients With Functional Constipation.

Boehringer Ingelheim27 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2007年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
368
试验地点
27
主要终点
Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Male and female patients, aged 18 and above
  • •Suffering from functional constipation, according to their medical history, as defined by the Rome III diagnostic criteria , i.e.:Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
  • •Must include 2 or more of the following::
  • •straining during at least 25% of the defecations
  • •lumpy or hard stools in at least 25% of the defecations
  • •sensation of incomplete evacuation for at least 25% of the defecations
  • •sensation of anorectal obstruction/blockade for at least 25% of the defecations
  • •manual manoeuvres to facilitate at least 25% of the defecations (e.g. digital evacuation, support of the pelvic floor)
  • •fewer than 3 defecations per week
  • •Loose stools are rarely present without the use of laxatives
  • •There are insufficient criteria for irritable bowel syndrome (IBS)
  • •Able and willing to complete a daily e-diary
  • •Able and willing to use the trial rescue medication
  • •Signed and dated written informed consent prior to enrolment into the study in accordance with GCP and local legislation
  • •At Visit 2, patients must comply with the following additional inclusion criteria to be eligible for entry into the treatment phase:
  • •Functional constipation is confirmed by e-diary data at the end of the baseline period:
  • •a. An average of less than 3 CSBMs per week, together with at least one of the following symptoms occurring at least 25% of the time:
  • •straining
  • •incomplete evacuation
  • •lumpy or hard stools (i.e. type 1 or type 2 stools)
  • •Compliant with the use of the e-diary throughout the baseline period (compliance is defined as completing 80% of the evening reports)
  • •Compliant with the use of rescue medication throughout the baseline period. Compliance is defined as follows:
  • •rescue medication may be used if there has not been a bowel movement for more than 72 hrs rescue medication may not be used on either day -1 or on the day of randomisation (day 1)

排除标准

  • •Eating disorders such as anorexia nervosa and bulimia, as a cause of excessive use of laxatives
  • •Patients whose constipation is caused by primary organic disease of the colon or pelvic floor
  • •Patients with metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that, in the Investigators opinion, would interfere with participation in the trial
  • •Patients with restricted mobility (e.g. wheelchair bound, or bed-ridden) that, in the Investigators opinion, would interfere with participation in the trial
  • •Patients with a known hypersensitivity to bisacodyl or any other ingredient in the study medication
  • •Patients with ileus, intestinal obstruction, acute surgical abdominal conditions (such as acute appendicitis and acute inflammatory bowel diseases), or severe dehydration
  • •Patients with anal fissures or ulcerative proctitis with mucosal damage
  • •Patients with known clinically significant abnormal electrolyte values
  • •Patients whose concomitant therapy includes an opioid medication (e.g. morphine, codeine)
  • •Constipation which, in the Investigators opinion, is caused by medication (e.g. anticholinergics)
  • •Patients who are not willing to discontinue the use of prohibited concomitant therapy
  • •Pre-menopausal women who:
  • •are nursing (breast-feeding) or who are pregnant OR
  • •who are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include:
  • •transdermal patch
  • •intra-uterine devices/systems (IUDs/IUSs)
  • •oral, implantable or injectable contraceptives
  • •sexual abstinence
  • •sterilisation or a vasectomised partner
  • •Participation in another trial with an investigational product with 1 month of enrolment into this study
  • •Drug or alcohol abuse

研究组 & 干预措施

Bisacodyl 5 mg x 2 once daily

Experimental

patient to receive two enteric-coated tablets containing 5 mg bisacodyl

干预措施: Bisacodyl 10 mg (Drug)

Placebo

Placebo Comparator

patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl

干预措施: Placebo (Drug)

结局指标

主要结局

Mean Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week Over the 4 Weeks Treatment Period

时间窗: 4 Weeks

A Complete Spontaneous Bowel Movement (CSBM) is a complete non-rescue medication-induced stool. The number of CSBMs in each of the 4 weeks was divided by the number of days where data were available in this week, multiplied by 7 and rounded off to the next integer. The sum of the resulting numbers were divided by the number of weeks with data.

次要结局

  • Number of SBMs at Week 3(Week 3 in treatment period)
  • Number of SBMs at Week 4(Week 4 in treatment period)
  • Number of Participants With an Increase of at Least 1 CSBM at Week 1 Compared to Baseline(Baseline and week 1 in treatment period)
  • Number of Participants Using Rescue Medication at Week 3 in the Treatment Period(Week 3 in the treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 2(Baseline and week 2 in treatment period)
  • Number of CSBMs at Week 1(Week 1 in treatment period)
  • Number of CSBMs at Week 3(Week 3 in treatment period)
  • Number of CSBMs at Week 4(Week 4 in treatment period)
  • Number of CSBMs at Week 2(Week 2 in treatment period)
  • Number of SBMs at Week 1(Week 1 in treatment period)
  • Time to the First SBM Following the First Dose of Study Medication (SM)(Time of first dose of SM up to 4 weeks)
  • Number of Participants With a Mean of at Least 1 CSBM a Day Over the 4 Weeks Treatment Period(4 weeks)
  • Number of Premature Withdrawals Over the 4 Weeks Treatment Period(4 weeks)
  • Number of Participants With an Increase of at Least 1 CSBM at Week 2 Compared to Baseline(Baseline and week 2 in treatment period)
  • Number of Premature Withdrawals at Week 1 in the Treatment Period(Week 1 in the treatment period)
  • Number of Participants Using Rescue Medication at Week 2 in the Treatment Period(Week 2 in the treatment period)
  • Mean Number of SBMs Per Week Over the 4 Weeks Treatment Period(4 Weeks)
  • Number of SBMs at Week 2(Week 2 in treatment period)
  • Number of Participants With an Increase of at Least 1 in the Mean Number of CSBMs Per Week Over the 4 Weeks Treatment Period Compared to Baseline(Baseline and 4 weeks)
  • Number of Participants With an Increase of at Least 1 CSBM at Week 3 Compared to Baseline(Baseline and week 3 in treatment period)
  • Number of Participants With an Increase of at Least 1 CSBM at Week 4 Compared to Baseline(Baseline and week 4 in treatment period)
  • Number of Premature Withdrawals at Week 2 in the Treatment Period(Week 2 in the treatment period)
  • Number of Premature Withdrawals at Week 3 in the Treatment Period(Week 3 in the treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 4(Baseline and week 4 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 3(Baseline and week 3 in treatment period)
  • Change From Baseline for Sodium (Normalized Value)(Baseline and 4 weeks)
  • Number of Participants With a Mean of at Least 3 CSBMs a Week Over the 4 Weeks Treatment Period(4 weeks)
  • Number of Premature Withdrawals at Week 4 in the Treatment Period(Week 4 in the treatment period)
  • Number of Participants Using Rescue Medication Over the 4 Weeks Treatment Period(4 weeks)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 3(Baseline and week 3 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 2(Baseline and week 2 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 1(Baseline and week 1 in treatment period)
  • Number of Participants Using Rescue Medication at Week 1 in the Treatment Period(Week 1 in the treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 1(Baseline and week 1 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 3(Baseline and week 3 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Straining' at Week 4(Baseline and week 4 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 2(Baseline and week 2 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 4(Baseline and week 4 in treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 4 in the Treatment Period in Comparison to Baseline(Baseline and week 4 in the treatment period)
  • Number of Participants With Respect to the Final Global Assessment of Tolerability by the Patient(4 weeks)
  • Change From Baseline in the SF-36 Dimension 'Physical Functioning'(Baseline and 4 weeks)
  • Number of Participants Using Rescue Medication at Week 4 in the Treatment Period(Week 4 in the treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Sensation of Incomplete Evacuation' at Week 1(Baseline and week 1 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 4(Baseline and week 4 in treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 4 in the Treatment Period in Comparison to Baseline(Baseline and week 4 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 2 in the Treatment Period in Comparison to Baseline(Baseline and week 2 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 1 in the Treatment Period in Comparison to Baseline(Baseline and week 1 in the treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Stool Quality' at Week 1(Baseline and week 1 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 4(Baseline and week 4 in treatment period)
  • Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 2 in the Treatment Period in Comparison to Baseline(Baseline and week 2 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 3 in the Treatment Period in Comparison to Baseline(Baseline and week 3 in the treatment period)
  • Change From Baseline in the SF-36 Dimension 'General Health'(Baseline and 4 weeks)
  • Change From Baseline in the SF-36 Mental Component Scale (MCS)(Baseline and 4 weeks)
  • Change From Baseline in the PAC-QoL Subscale 'Psychosocial Discomfort'(Baseline and 4 weeks)
  • Change From Baseline in the PAC-QoL Overall Score(Baseline and 4 weeks)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 1(Baseline and week 1 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 2(Baseline and week 2 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Anorectal Obstructions/Blockade' at Week 3(Baseline and week 3 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 2(Baseline and week 2 in treatment period)
  • Change From Baseline in the Mean Score for Constipation Symptom 'Manual Manoeuvre' at Week 3(Baseline and week 3 in treatment period)
  • Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 3 in the Treatment Period in Comparison to Baseline(Baseline and week 3 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 1 in the Treatment Period in Comparison to Baseline(Baseline and week 1 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 2 in the Treatment Period in Comparison to Baseline(Baseline and week 2 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 3 in the Treatment Period in Comparison to Baseline(Baseline and week 3 in the treatment period)
  • Change From Baseline in the SF-36 Dimension 'Vitality'(Baseline and 4 weeks)
  • Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 1 in the Treatment Period in Comparison to Baseline(Baseline and week 1 in the treatment period)
  • Number of Participants With Improved, Unchanged or Worsened Overall Satisfaction With Bowel Habits at Week 4 in the Treatment Period in Comparison to Baseline(Baseline and week 4 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Constipation at Week 2 in the Treatment Period in Comparison to Baseline(Baseline and week 2 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 1 in the Treatment Period in Comparison to Baseline(Baseline and week 1 in the treatment period)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Bloating at Week 3 in the Treatment Period in Comparison to Baseline(Baseline and week 3 in the treatment period)
  • Number of Participants With Respect to the Final Global Assessment of Efficacy by the Investigator(4 weeks)
  • Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Physical Problems'(Baseline and 4 weeks)
  • Change From Baseline in the SF-36 Dimension 'Bodily Pain'(Baseline and 4 weeks)
  • Number of Participants With Reduced, Unchanged or Increased Bothersomeness With Abdominal Discomfort at Week 4 in the Treatment Period in Comparison to Baseline(Baseline and week 4 in the treatment period)
  • Number of Participants With Respect to the Final Global Assessment of Efficacy by the Patient(4 weeks)
  • Number of Participants With Respect to the Final Global Assessment of Tolerability by the Investigator(4 weeks)
  • Change From Baseline in the SF-36 Dimension 'Social Functioning'(Baseline and 4 weeks)
  • Change From Baseline in the PAC-QoL Subscale 'Worries and Concerns'(Baseline and 4 weeks)
  • Change From Baseline in the SF-36 Dimension 'Role Limitation Due to Emotional Problems'(Baseline and 4 weeks)
  • Change From Baseline in the SF-36 Dimension 'Mental Health'(Baseline and 4 weeks)
  • Change From Baseline in the SF-36 Physical Component Scale (PCS)(Baseline and 4 weeks)
  • Change From Baseline for Potassium (Normalized Value)(Baseline and 4 weeks)
  • Change From Baseline in the PAC-QoL Subscale 'Physical Discomfort'(Baseline and 4 weeks)
  • Change From Baseline in the PAC-QoL Subscale 'Satisfaction'(Baseline and 4 weeks)
  • Change From Baseline for Chloride (Normalized Value)(Baseline and 4 weeks)

研究者

申办方类型
Industry

研究点 (27)

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