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Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia

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ClinicalTrials.gov Identifier: NCT02931565
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:

The objectives of this study are as follows:

In patients with primary Type I or II Achalasia, following a single 5-mg dose of IW-1701,

  • To assess the safety and tolerability
  • To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM)
  • To determine the pharmacokinetic (PK) parameters, Cmax, Tmax, and AUClast

Condition or disease Intervention/treatment Phase
Achalasia Drug: IW-1701 Drug: Matching Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single-dose, Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 in Patients With Achalasia
Actual Study Start Date : February 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: IW-1701
Single 5-mg dose of IW-1701 administered orally
Drug: IW-1701
Placebo Comparator: Placebo
Matching placebo administered orally
Drug: Matching Placebo



Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: Within 28 days from dosing day (Day 1) ]
  2. Change in Integrated Relaxation Pressure (IRP) as measured by HRIM [ Time Frame: 1 day (Dosing day/ Day 1) ]
  3. Maximum observed plasma concentration [Cmax] [ Time Frame: Within 28 days of dosing day (Day 1) ]
    Maximum observed plasma concentration

  4. Area under the plasma concentration time curve during a dosing interval [AUC] [ Time Frame: Within 28 days of dosing day (Day 1) ]
    Area under the plasma concentration time curve during a dosing interval

  5. Time of maximum observed plasma concentration [Tmax] [ Time Frame: Within 28 days of dosing day (Day 1) ]
    Time of maximum observed plasma concentration



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a diagnosis of primary Type I or II achalasia.
  • Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion.

Exclusion Criteria:

  • Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent.
  • More than 1 pneumatic dilation procedure to a diameter of >2 cm in their lifetime.
  • Pneumatic dilation procedure to a diameter of >2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.
  • Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime.
  • Patients with malignant or premalignant esophageal lesions.
  • Patient has taken any drug that can affect GI motility in the 72 hours before Check-in through Discharge from the clinic.
  • Other exclusion criteria specified in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931565


Contacts
Contact: Jayita Sen C1701-201@ironwoodpharma.com

Locations
United States, Connecticut
Connecticut Clinical Research Foundation, Gastroenterology Institute Recruiting
Bristol, Connecticut, United States, 06010
Contact: Cecile Guttermuth, PhD    860-585-3838    cgutterm@bristolhospital.org   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Deborah M Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
United States, Missouri
Washington University in St. Louis - School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Terri Radake, RN, CRCC    314-747-5366    radaket@wustl.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Tina C Higginbotham, MPA    615-322-4643    tina.higginbotham@vanderbilt.edu   
United States, Utah
University of Utah School of Medicine, Division of Gastroenterology, Hepatology & Nutrition Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Linda Taylor    801-581-8051    lindajo.taylor@hsc.utah.edu   
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02931565     History of Changes
Other Study ID Numbers: C1701-201
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases