Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Phase 3

Completed

Conditions: Constipation
Irritable Bowel Syndrome

Registration Number: NCT00399542

Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary: The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 581

Inclusion Criteria

18 years of age and older
Stable fiber therapy
Normal colonoscopy/sigmoidoscopy
Able to refrain from use of medications known to treat or associated with constipation symptoms
Experiences abdominal discomfort/pain associated with bowel movements
Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria

Diarrhea-predominant or alternating (diarrhea & constipation cycling) IBS, or constipation other than that associated with IBS
Open gastrointestinal or abdominal surgery prior to IBS onset
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Responder Status	12 weeks	Overall responder: monthly responder for at least 2 out of 3 months Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.

Secondary Outcome Measures

Name	Time	Method
Month 3 Abdominal Bloating Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Responder Rate	28 days	Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Month 3 Responder Rate	28 days	Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Month 3 Constipation Severity Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Stool Consistency Change From Baseline	28 days	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Month 2 Symptom Relief	28 days	* 3 = Significantly worse, -2 = Moderately worse, * 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Month 1 Constipation Severity Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Symptom Relief	28 days	* 3 = Significantly worse, -2 = Moderately worse, * 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Month 2 Abdominal Bloating Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Spontaneous Bowel Movement Rates Change From Baseline	28 days	Any bowel movement not associated with rescue medication use
Month 2 Stool Consistency Change From Baseline	28 days	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Month 1 Bowel Movement Rates Change From Baseline	28 days
Month 1 Spontaneous Bowel Movement Rates Change From Baseline	28 days	Any bowel movement not associated with rescue medication use
Month 1 Bowel Straining Change From Baseline	28 days	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Abdominal Pain Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Abdominal Pain Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 1 Abdominal Bloating Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 3 Stool Consistency Change From Baseline	28 days	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Month 1 Responder Rate	28 days	Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
Month 3 Abdominal Pain Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 3 Spontaneous Bowel Movement Rates Change From Baseline	28 days	Any bowel movement not associated with rescue medication use
Month 2 Bowel Straining Change From Baseline	28 days	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 3 Bowel Straining Change From Baseline	28 days	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 2 Constipation Severity Change From Baseline	28 days	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Month 3 Symptom Relief	28 days	* 3 = Significantly worse, -2 = Moderately worse, * 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Month 3 Quality of Life Change From Baseline	12 weeks	IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase
Month 2 Bowel Movement Rates Change From Baseline	28 days
Month 3 Bowel Movement Rates Change From Baseline	28 days