Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Browse trials for

• Constipation 1,018

Keywords

• Constipation
• Chronic Constipation
• Microbia
• linaclotide
• linaclotide acetate
• MD-1100

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 310 is above the median of 80 across 850 interventional studies indexed under Constipation.

Lead sponsor

Ironwood Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Study arms

• Active comparator
  72 ug linaclotide acetate

  Drug: linaclotide acetate

• Active comparator
  145 ug linaclotide acetate

  Drug: linaclotide acetate

• Active comparator
  290 ug linaclotide acetate

  Drug: linaclotide acetate

• Active comparator
  579 ug linaclotide acetate

  Drug: linaclotide acetate

• Placebo comparator
  Matching Placebo

  Drug: Matching placebo

Interventions

• Druglinaclotide acetate

  oral, once daily.

• DrugMatching placebo

  oral, once daily

Primary outcomes

1. Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency

   Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

   Time frame: Change from Baseline to Week 4

Secondary outcomes

1. SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

   A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate.

   Time frame: Change from Baseline to Week 4

2. CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

   A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate.

   Time frame: Change from Baseline to Week 4

3. Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period

   CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?

   Time frame: Change from Baseline to Week 4

4. Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period

   Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.

   Time frame: Change from Baseline to Week 4

5. Change From Baseline in Straining Score for the Treatment Period

   Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.

   Time frame: Change from Baseline to Week 4

Baseline characteristics

Publications

• Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4. PubMed 20045700 ↗