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Befejeződött3. fázis

Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

A legfontosabb adatok

Ki végzi
AbbVie
Hol
Albuquerque, Anaheim, Atlanta, Aurora, Birmingham, Blue Ridge, Bridgeton, Charleston, Corona, Doral, East Orange, Flowood, Foley, Fort Worth, Franklin, Greenville, Harlingen, Hialeah, Hot Springs, Houston, Jackson, Jacksonville, Jefferson City, Lexington, Little Rock, Miami, Minneapolis, Naples, New York, Newport News, Oklahoma City, Orlando, Oviedo, Paramount, Plano, Port Gibson, Providence, Richmond, San Antonio, San Diego, Saraland, Scottdale, Silver Spring, Smithfield, St. George, Statesville, Stockbridge, Summerville, Tacoma, The Bronx, Washington D.C., Waxahachie és Wichita (Egyesült Államok)Mind a 65 helyszín megnézéseMég 3 másik országban, 7 helyszínen
Állapot
Befejeződött
Fázis
3. fázis
Résztvevők
381 fő vett részt
Kezdés
2019. nov. 19.
Befejezés
2025. jún. 5.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
  • Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
A regiszteradat frissítve
2026. január 6.

Ki vehet részt

Életkor
6 év – 18 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 19 feltétel megnézéseKevesebb

Ki vehet részt

  • Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent
  • Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception
  • Participants must have completed study intervention in their lead-in study
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2)

Ki nem vehet részt

  • Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study
  • Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention
  • Participant has had surgery that meets any of the following criteria:; a) Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit (Visit 1); b) Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit (Visit 1); c) An appendectomy or cholecystectomy during the 60 days before the Screening Visit; d) Other major surgery during the 30 days before the Screening Visit (Visit 1)
  • Participant is receiving enteral tube feeding
  • Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation
  • Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids
  • Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class
  • Participant has any of the following conditions:; a) Down's syndrome or any other chromosomal disorder; b) Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus); c) Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies); d) Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma); e) Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension by the participant
  • Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process
  • Participant has an active anal fissure (Note: history of anal fissure is not an exclusion)
  • Participant has a history of nonretentive fecal incontinence
  • Participant has a history of drug or alcohol abuse
  • Participant has any of the following conditions:; a) Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy; b) Cystic fibrosis; c) Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening (Visit 1); d) Lead toxicity, hypercalcemia; e) Inflammatory bowel disease; f) Childhood functional abdominal pain syndrome; g) Childhood functional abdominal pain; h) Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study; i) Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study; j) History of cancer other than treated basal cell carcinoma of the skin. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.); k) History of diabetic neuropathy
  • Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study
  • Participant has a mechanical bowel obstruction or pseudo-obstruction

Helyszínek itt: Egyesült Államok

Még 3 másik országban, 7 helyszínen

  • University of New Mexico /ID# 236983Albuquerque, Egyesült ÁllamokNo longer taking part
  • Advanced Research Center /ID# 237960Anaheim, Egyesült ÁllamokNo longer taking part
  • Children's Ctr Digestive, US /ID# 237574Atlanta, Egyesült ÁllamokNo longer taking part
  • Children's Healthcare of Atlanta - Ferry Rd /ID# 237005Atlanta, Egyesült ÁllamokNo longer taking part
  • Treken Primary Care /ID# 234645Atlanta, Egyesült ÁllamokNo longer taking part
  • Lynn Institute of Denver /ID# 238086Aurora, Egyesült ÁllamokNo longer taking part
  • Central Research Associates /ID# 237953Birmingham, Egyesült ÁllamokNo longer taking part
  • River Birch Research Alliance /ID# 237963Blue Ridge, Egyesült ÁllamokNo longer taking part
  • Private Practice - Dr. Craig Spiegel /ID# 234545Bridgeton, Egyesült ÁllamokNo longer taking part
  • Coastal Pediatric Research - West Ashley B /ID# 234678Charleston, Egyesült ÁllamokNo longer taking part
  • Kindred Medical Institute, LLC /ID# 237367Corona, Egyesült ÁllamokNo longer taking part
  • Dolphin Medical Research /ID# 234676Doral, Egyesült ÁllamokNo longer taking part
  • Prohealth Research Center /ID# 234659Doral, Egyesült ÁllamokNo longer taking part
  • Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566East Orange, Egyesült ÁllamokNo longer taking part
  • GI associates and Endoscopy Ce /ID# 237969Flowood, Egyesült ÁllamokNo longer taking part
  • G & L Research, LLC /ID# 238093Foley, Egyesült ÁllamokNo longer taking part
  • Cook Children's Med. Center /ID# 237536Fort Worth, Egyesült ÁllamokNo longer taking part
  • Office of Maria Ona /ID# 234539Franklin, Egyesült ÁllamokNo longer taking part
  • East Carolina University - Brody School of Medicine /ID# 237509Greenville, Egyesült ÁllamokNo longer taking part
  • Valley Institute of Research /ID# 234475Harlingen, Egyesült ÁllamokNo longer taking part
  • Amedica Research Institute Inc /ID# 234666Hialeah, Egyesült ÁllamokNo longer taking part
  • HealthStar Research of Hot Springs PLLC /ID# 234608Hot Springs, Egyesült ÁllamokNo longer taking part
  • Cullen Research /ID# 234482Houston, Egyesült ÁllamokNo longer taking part
  • Pioneer Research Solutions - Houston /ID# 236935Houston, Egyesült ÁllamokNo longer taking part
  • Vilo Research Group Inc /ID# 238228Houston, Egyesült ÁllamokNo longer taking part
  • The Jackson Clinic, PA /ID# 236772Jackson, Egyesült ÁllamokNo longer taking part
  • Nemours Childrens Specialty Care /ID# 237991Jacksonville, Egyesült ÁllamokNo longer taking part
  • Accellacare of Knoxville /ID# 234462Jefferson City, Egyesült ÁllamokNo longer taking part
  • Michael W. Simon, MD, PSC /ID# 236516Lexington, Egyesült ÁllamokNo longer taking part
  • Applied Research Center of Arkansas /ID# 238069Little Rock, Egyesült ÁllamokNo longer taking part
  • Preferred Research Partners /ID# 237109Little Rock, Egyesült ÁllamokNo longer taking part
  • Elite Clinical Research /ID# 234651Miami, Egyesült ÁllamokNo longer taking part
  • My Preferred Research LLC /ID# 237943Miami, Egyesült ÁllamokNo longer taking part
  • South Miami Medical & Research Group Inc. /ID# 234654Miami, Egyesült ÁllamokNo longer taking part
  • Valencia Medical & Research Center /ID# 234671Miami, Egyesült ÁllamokNo longer taking part
  • MNGI Digestive Health, P. A. /ID# 234437Minneapolis, Egyesült ÁllamokNo longer taking part
  • Advanced Research for Health Improvement /ID# 238253Naples, Egyesült ÁllamokNo longer taking part
  • Columbia University Irving Medical Center /ID# 235686New York, Egyesült ÁllamokNo longer taking part
  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252Newport News, Egyesült ÁllamokNo longer taking part
  • IPS Research Company /ID# 237669Oklahoma City, Egyesült ÁllamokNo longer taking part
  • Univ Oklahoma HSC /ID# 237546Oklahoma City, Egyesült ÁllamokNo longer taking part
  • Nemours Children's Hospital /ID# 234429Orlando, Egyesült ÁllamokNo longer taking part
  • Pediatric & Adult Research Center /ID# 234681Orlando, Egyesült ÁllamokNo longer taking part
  • Oviedo Medical Research /ID# 234692Oviedo, Egyesült ÁllamokNo longer taking part
  • Duplicate_Center for Clinical Trials LLC /ID# 234629Paramount, Egyesült ÁllamokNo longer taking part
  • AIM Trials /ID# 236364Plano, Egyesült ÁllamokNo longer taking part
  • David M. Headley, MD, P.A. /ID# 238216Port Gibson, Egyesült ÁllamokNo longer taking part
  • Rhode Island Hospital /ID# 237861Providence, Egyesült ÁllamokNo longer taking part
  • Clinical Research Partners, LLC /ID# 237158Richmond, Egyesült ÁllamokNo longer taking part
  • Sun Research Institute /ID# 236932San Antonio, Egyesült ÁllamokNo longer taking part
  • Medical Ctr for Clin Research /ID# 236911San Diego, Egyesült ÁllamokNo longer taking part
  • The Center for Clinical Trials Inc. /ID# 234605Saraland, Egyesült ÁllamokNo longer taking part
  • Frontier Clinical Research, LLC - Scottdale /ID# 238022Scottdale, Egyesült ÁllamokNo longer taking part
  • Virgo Carter Pediatrics /ID# 234518Silver Spring, Egyesült ÁllamokNo longer taking part
  • Duplicate_Frontier Clinical Research /ID# 237923Smithfield, Egyesült ÁllamokNo longer taking part
  • Duplicate_Chrysalis Clinical Research /ID# 234515St. George, Egyesült ÁllamokNo longer taking part
  • PMG Research of Piedmont Healthcare-Statesville /ID# 238257Statesville, Egyesült ÁllamokNo longer taking part
  • Clinical Research Institute /ID# 234702Stockbridge, Egyesült ÁllamokNo longer taking part
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342Stockbridge, Egyesült ÁllamokNo longer taking part
  • Coastal Pediatric Research - Summerville /ID# 234674Summerville, Egyesült ÁllamokNo longer taking part
  • Duplicate_Multicare Institute for Research and Innovation /ID# 236979Tacoma, Egyesült ÁllamokNo longer taking part
  • Advantage Clinical Trials /ID# 237932The Bronx, Egyesült ÁllamokNo longer taking part
  • Childrens National Medical Center /ID# 234417Washington D.C., Egyesült ÁllamokNo longer taking part
  • ClinPoint Trials /ID# 236615Waxahachie, Egyesült ÁllamokNo longer taking part
  • KU Wichita Center for Clinical Research /ID# 234500Wichita, Egyesült ÁllamokNo longer taking part

A vizsgálatról

Mit akar kideríteni a vizsgálat

LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.

A vizsgálat 3 csoportja

  • 72 μg linaclotideMár használt kezelés, összehasonlításként

    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

    Kezelés: Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

  • 145 μg linaclotideMár használt kezelés, összehasonlításként

    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

    Kezelés: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) és Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

  • 290 μg linaclotideMár használt kezelés, összehasonlításként

    An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

    Kezelés: Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants With Functional Constipation (FC) or Irritable Bowel Syndrome With Constipation (IBS-C)
A regiszteradat frissítve
2026. január 6.