The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01447849
• Date of registration: 14/09/2011
• Primary sponsor: Texas Tech University Health Sciences Center
• Public title: The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation
• Scientific title: The Impact of Lubiprostone on Mucus Secretion in Asymptomatic Volunteers and Patients With Chronic Constipation
• Date of first enrolment: August 2011
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01447849
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jerzy Sarosiek, MD, PhD

• Name: Jerzy Sarosiek, MD, PhD
• Affiliation: Texas Tech University Health Sciences Center

Key inclusion & exclusion criteria

Asymptomatic Volunteers:

Inclusion Criteria:

- 18-65 years of age

- Capable of and willing to give informed consent, and willing to comply with all study
requirements

Exclusion Criteria:

- 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:

Inclusion Criteria:

- 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

Exclusion Criteria

- 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)

- Use of any of the following drugs within 3 days prior to randomization a) Prokinetic
agents (tegaserod, domperidone, cisapride, metoclopramide, erythromycin, b)
Medications containing opiates c) Antispasmodic (e.g. atropine, hyoscyamine,
scopolamine, glycopyrrolate)

- Use of illegal drugs

- Regular consumption of 2 drinks of alcohol per day

- Chronic NSAIDs use

- Chronic use of H2 receptor antagonist or PPIs within 14 days prior to screening

- History of gastric or duodenal ulcer, Inflammatory bowel disease (IBD), or chronic
non-ulcer dyspepsia

- Diabetes mellitus (DM) type 1

- Parkinson's disease

- Existence of any medical condition that requires chronic therapy

- Positive H. pylori serology



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Constipation

Intervention(s)

Drug: Lubiprostone

Drug: Placebo Comparator

Primary Outcome(s)

Increase in volume and concentration of mucus and mucin secretion per millileter of solution in controls and patients with chronic constipation. [Time Frame: Measured at baseline and 1 week after baseline]

Secondary Outcome(s)

Increase in amount of viscoelasticity of gastric secretion in controls and patients with chronic constipation. [Time Frame: Measured at baseline and 1 week after baseline]

Secondary ID(s)

07-022L

Source(s) of Monetary Support

Please refer to primary and secondary sponsors