Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.

NCT01135186 | Completed Results

• 1 other identifier: SU-03252010-5462
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Gastric Accommodation

  Gastric Accommodation refers to the reflexive relaxation of the upper stomach after swallowing as measured by the Satiety Test at baseline, 4 weeks, and 8 weeks. Increased gastric accommodation is considered a positive outcome.

  Baseline, 4 Weeks, 8 Weeks

Secondary Outcomes (3)

• Secondary Outcome Measures Will Include Change in Symptom Severity.

  Baseline, 4 Weeks, 8 Weeks

• Secondary Outcome Measures Will Include Change in Quality of Life.

  Baseline, 4 Weeks, 8 Weeks

• Secondary Outcome Measures Will Include Change in Symptom Severity as Measured by the Patient Assessment of Gastrointestinal Disorder-Symptom Severity Index Disorders Symptom Severity Index (PAGI-SYM)

  Baseline, 4 Weeks, 8 Weeks

Study Arms (1)

Sapropterin

OTHER

open label study of sapropterin dihydrochloride

Drug: sapropterin dihydrochloride

Interventions

sapropterin dihydrochloride DRUG

sapropterin dihydrochloride: 10mg/kg/day

Also known as: KUVAN

Sapropterin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetes mellitus \> 5 years requiring medical therapy
• Female gender
• Ages 18-65 years
• Documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment)
• Symptoms of gastroparesis for at least 6 months with Gastroparesis Cardinal Symptom Index (GCSI) score \> 21 indicating moderate to severe symptoms
• Recent negative upper endoscopy or upper GI series within 2 years of enrollment (no evidence of mechanical obstruction or peptic ulcer disease)

You may not qualify if:

• Diabetes diagnosed \< 5 years prior to the study
• Male gender
• Normal gastric emptying
• Gastroparesis from post-surgical etiologies
• Another active disorder, which could explain symptoms in the opinion of the investigator
• Pregnancy
• History of significant cardiac arrhythmias and/or prolonged QTc
• Daily use of narcotic analgesics for abdominal pain
• Contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae.
• Underlying seizure disorder
• Known history of cardiac ischemia
• Recent clinically significant gastrointestinal bleeding
• Patients taking Levodopa
• Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
• Failure to give informed consent

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (6)

• Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical characteristics, psychological and abuse profiles, treatment, and long-term follow-up of patients with gastroparesis. Dig Dis Sci. 1998 Nov;43(11):2398-404. doi: 10.1023/a:1026665728213.

  PMID: 9824125 BACKGROUND

• Bell RA, Jones-Vessey K, Summerson JH. Hospitalizations and outcomes for diabetic gastroparesis in North Carolina. South Med J. 2002 Nov;95(11):1297-9.

  PMID: 12539997 BACKGROUND

• Stacher G. Diabetes mellitus and the stomach. Diabetologia. 2001 Sep;44(9):1080-93. doi: 10.1007/s001250100619.

  PMID: 11596661 BACKGROUND

• Gangula PR, Maner WL, Micci MA, Garfield RE, Pasricha PJ. Diabetes induces sex-dependent changes in neuronal nitric oxide synthase dimerization and function in the rat gastric antrum. Am J Physiol Gastrointest Liver Physiol. 2007 Mar;292(3):G725-33. doi: 10.1152/ajpgi.00406.2006.

  PMID: 17347455 BACKGROUND

• Werner ER, Gorren AC, Heller R, Werner-Felmayer G, Mayer B. Tetrahydrobiopterin and nitric oxide: mechanistic and pharmacological aspects. Exp Biol Med (Maywood). 2003 Dec;228(11):1291-302. doi: 10.1177/153537020322801108.

  PMID: 14681545 BACKGROUND

• Smirnova VI, Gridchik IE, Tregubenko AD, Khachaturova EA. [Analgesia and intensive therapy during hemicorporectomy]. Anesteziol Reanimatol. 1991 Sep-Oct;(5):46-8. Russian.

  PMID: 1767961 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Interventions

sapropterin

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A larger sample size is required to confirm the efficacy of saproptetin in increasing gastric accommodation and decreasing gastroparesis symptoms. This would assist in optimal dosing and duration of therapy.

Results Point of Contact

• Title: Dr. Linda Anh B. Nguyen
• Organization: Stanford University

nguyenlb@stanford.edu

650-736-5555

Study Officials

• Linda A Nguyen

  Stanford University

  PRINCIPAL INVESTIGATOR

• Pankaj Jay Pasricha

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 10, 2019
• Results First Posted: March 29, 2017

Record last verified: 2019-09

Locations

US (1)