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NCT01460225 Clinical Trial

Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

Official title:
Effects of Lubiprostone on Gastric Sensory and Motor Function in Patients With Chronic Idiopathic Constipation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01460225
Other study ID # 07-033L
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2007
Est. completion date January 2011

Study information
Verified date July 2018
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This prospective study is designed to evaluate how lubiprostone may affect gastric motor and sensory function.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date January 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- chronic idiopathic constipation

Exclusion Criteria:

- medications that slow gastrointestinal (GI) motility

- prior surgery to the GI tract

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lubiprostone
24 micrograms twice daily for 1 week

Locations
Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)
Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastric Emptying gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal) Day 1 and Day 7
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02361749 - Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation Phase 4
Terminated NCT02239510 - Efficacy of Linaclotide to Senna for CIC N/A
Completed NCT01895543 - Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation Phase 3
Completed NCT02291679 - Trial of Linaclotide in Patients With Chronic Idiopathic Constipation Phase 3
Completed NCT01993875 - Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation Phase 3
Completed NCT01989234 - A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation Phase 2
Completed NCT01674530 - Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation Phase 3
Completed NCT01429987 - The Plecanatide Chronic Idiopathic Constipation (CIC) Study Phase 2/Phase 3
Completed NCT01982240 - 12-Week Study of Plecanatide for CIC (The CIC3 Study) Phase 3
Completed NCT02590432 - An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation Phase 4
Completed NCT02481947 - A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults Phase 3
Completed NCT01372423 - Evaluation of Clinical Equivalence Between Two Lubiprostone Products Phase 3
Completed NCT03054506 - The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation N/A
Recruiting NCT04804267 - Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation Phase 3
Completed NCT03879239 - Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation N/A
Completed NCT01053962 - SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation Phase 2
Completed NCT03097861 - Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo Phase 3
Completed NCT03551873 - A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
Completed NCT02819297 - BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults Phase 3
Completed NCT02819310 - An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults Phase 3