Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

NCT01447849 | Completed Phase 2 Results

• 2 other identifiers: MSA-LUB-125MSA-NC-LUB-125
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the symptoms of chronic constipation in some patients are developed due to diminished production and secretion of the alimentary tract mucus resulting in poor lubrication. Therefore, the investigators assume that administration of lubiprostone may restore this lubrication impairment by stimulation of mucus production and secretion within the gastrointestinal tract.

Conditions

Constipation

Keywords

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

• Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.

  The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).

  Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.

Secondary Outcomes (1)

• Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.

  Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.

Study Arms (2)

Lubiprostone 24 mcg Twice a day

ACTIVE COMPARATOR

Both controls and patients with chronic constipation will receive 1 week of therapy with lubiprostone and one week of placebo.

Drug: lubiprostone

Placebo

PLACEBO COMPARATOR

Both controls and patients with chronic constipation will receive placebo pills twice daily for one week in cross over design

Drug: placebo

Interventions

lubiprostone DRUG

24mcg twice a day (BID) 1 week

Also known as: Amitiza

Lubiprostone 24 mcg Twice a day

placebo DRUG

Placebo pills twice a day for one week.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Capable of and willing to give informed consent, and willing to comply with all study requirements

You may not qualify if:

• Pregnancy or lactation
• Subjects unwilling to practice adequate contraception throughout the screening period through 14 days after study termination
• Illegal use of illegal drugs
• Regular consumption of 2 or more drinks of alcohol per day
• Chronic non-steroidal anti- inflammatory drugs (NSAID) use
• Chronic use of H2 receptor antagonists or Proton Pump Inhibitors (PPIs) within 14 days prior to screening
• History of gastric of duodenal ulcer or chronic non-ulcer dyspepsia
• Positive Helicobacter pylori (H. pylori) serology
• Patients with Chronic Constipation:
• Age 18-65
• At least 6 months history of constipation. Constipation defined as: a. Less than three complete spontaneous bowel movements per week and one or more of the following: i) At least 25% of stools are very hard and/or hard stools ii) Sensation of incomplete evacuation following at least 25% of bowel movements iii) Straining on at least 25% of defecations The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study
• For patients \>= years of age, normal colonic anatomy as documented by colonoscopy, double-contrast barium enema, or flexible sigmoidoscopy performed within the previous 5 years
• Pregnancy or lactation
• Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after study termination
• Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents)

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Jerzy Sarosiek, Director, Mol. Medicine Research
• Organization: TexasTech

jerzy.sarosiek@ttuhsc.edu

915-215-5255

Study Officials

• Jerzy Sarosiek, MD, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Associate Chairman for Research, Internal Medicine Department

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: October 6, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 9, 2017
• Results First Posted: September 23, 2013

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)